Vertex Pharmaceutical's (VRTX) Telaprivir is effective, but path to market needs clarification

The results look impressive as they show a rapid response in Telaprivir treated patients vs. plaebo in the first 4 weeks. However, the interpretation of results at 12 weeks becomes questinable due to lack of statistical significance. Analysts were focusing on a small subset of 20 patients who were to receive the Vertex drug for just 12 weeks and then be checked 20 weeks later for signs of relapse. Here is the quoted text from the press release regarding those 20 patients:

"Analysis of PROVE 1 Patients who Finished All Treatment at 12 Weeks. Seventeen of 175 patients received at least one dose of telaprevir in “Arm D” of the PROVE 1 study (telaprevir + peg-IFN + RBV). According to the study protocol, patients in Arm D were eligible to stop all treatment at week 12 if they met on-treatment criteria, including the achievement of RVR (<10>The one obvious conclusion that can be made from looking at this data is that the number of patients are too low to make any extrapolation on percent responders. The other conclusion is that 12 week therapy may not be sufficient to reach undetectable levels in a significant portion of the patients. However, the fact that more patients respond to longer periods of treatment with standard of care ( SOC is Interferon + Rivbavirin) suggests that patients on SOC + TVR may also benefit from this increase. The company has already started Phase II ( Prove 2 and 3) trials with larger number of patients with regimens of at least 24 weeks. This means longer clinical trials, higher costs of trials and lower chance of a quick approval and launch in 2009. This would explain lack of a upward stock movement after the release of the results.

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Altus Pharmaceuticals (ALTU) is showing clinical and financial progress

Altus Pharmaceuticals (ALTU) is a small cap (~$400M) market cap biopharmaceutical company with a unique crystallization technology that amongst other things allows for better purity and longer half life for other wise rapidly broken down proteins and enzymes. This technology is very difficult to master and creates a natural barrier to entry even beyond patent expiration. I have previously written about ALTU when the stock was trading around $18 back in November 2006 (link).


Since then Altus has signed a development and commercialization agreement with Genentech (DNA) (link) for ALTU-238 a longer acting version of human growth hormone currently in phase II clinical trials with a $2 billion market.


On May 10th, Altus announced initiation of a phase III clinical trial for ALTU-135, an enzyme replacement therapy for Cystic Fibrosis. To fund this large and expensive trial, Altus had a stock offering earlier this year which raised about $89 Million dollars.


Altus' pipeline contains other promising pre-clinical products including ALTU -237 (oral)for kidney stones and ALTU-236 (oral) for phenyloketonurea.


Altus has a high probability of success mostly because of their first two products are improved versions of existing products, which lowers the degree of difficulty because they do not have the burden of a proof-of-principal that a novel medicine must overcome.


For some strange reason, Altus' financials do not reflect the new money raised through public offering. The correct balance sheet cash should be closer to $200 million. The company is undervalued with a market cap of only $413 million at $13/share with about $6/share in cash, a partnership with Genentech and two products in or near phase III. I expect the stock to rise to $20-25 by year end as more clinical trial data becomes available or a new phase III is started for ALTU-238.

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February Performance Update and reflections on past picks

Looking back, I am still happy with the picks I have made so far. ALTU, ARNA and VRTX are obvious laggards but I think 2007 will be a good year for all of these good small and mid sized biotechs as clinical trial results become available.

What stands out was the good decision to get out of CELG and VRTX based on valuations. I still don't like CELG at $54 but at $32 I like VRTX a lot and I am waiting for a better buying opportunity around $30. Meanwhile, I am selling more April $20 puts to take advantage of time decay of option values since there is not going to be much news announced in the next two months. I believe VRTX stock is being punished because the management has decided to release already available clinical data in April at medical conferences. Investors, being a paranoid bunch, have decided to sell the stock and wait for those results before making up their mind about this product and the company. I think those results will be positive and VRTX will end up moving much higher. I will start to buy both shares and long-term options in VRTX in the coming weeks.

As far as the rest of the market, I anticipate a correction of 5-10%(which probably just started) in the first half of this year due to lower anticipated earnings and uncertainties around oil prices and inflation. So, I am a bit bearish with most of stocks out there. This summer should bring a much better buying opportunity. I am particularly interested in tech names that I do not own such as BRCM, AAPL and GOOG as well as some financial and energy stocks.

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Onyx Pharmaceutical's (ONXX) success may pave the way for competition

Onyx Pharmaceutical (ONXX) is enjoying the rewards of its potential blockbuster, Nexavar. On Monday, November 19th, FDA approved Nexavar, already approved for Kidney Cancer, for treatment of liver cancer. The product did so well in clinical trials that the company and its partner Bayer had to halt the trials for ethical reasons to give Nexavar to the control group as well.


Onyx's stock has been doing tremendously well. In 2007, it has raised more than 500% from about $10 to its current price of $53, but off of its 52 week high of $61.

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Gene's mutations found to cause life-threatening aortic disease

Scientists have identified the first genetic mutations that cause the aorta – the body's main artery – to widen, tear and rupture. Finding biological markers that flag aneurysm, a bulging of the aorta that leads to dissection, a lengthwise separation of tissues in the artery wall, is critically important for early diagnosis. Aneurysms can be managed initially with medication and then successfully repaired to prevent catastrophic dissection and rupture, Milewicz said. Many patients never have a chance at treatment because they go undiagnosed, even when they go to emergency rooms with severe chest pain because diagnostic tests for heart attack do not uncover aortic defects. Actor John Ritter, for example, died in September 2003 from an undiagnosed dissection that ruptured.

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New Poll Feature on Biotechnology Stock Blog

In an attempt to have a more interactive blog and to hear more feedback from subscribers I have decided to add a Polling feature. You can find this tool on the right hand side of this page. I am hoping this tool will allow all of us to see the majority's response to a particular investment related topic and compare it to our own personal views. With 116 subscribers the results should be statistically significant. Also, you can suggest Poll questions by emailing me at arsaadat1@gmail.com

The first Poll question is a very general question regarding your sentiment on the Biotechnology sector in 2008. I happen to be very bullish (greater than 25% return). I am interested to see how the majority feels. Going foreword, I am thinking about asking questions regarding small cap or large cap biotech sectors and individual stocks.

Again, your feedback is extremely beneficial.

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Drug Patent Expirations in October 2010

Drug Patent Expirations in October 2010 *Drugs may be covered by multiple patents Tradename Applicant Generic Name Patent Number Patent Expiration ORGARAN Organon Usa Inc danaparoid sodium 5,164,377 Oct 3, 2010 MIRAPEX ER Boehringer Ingelheim pramipexole dihydrochloride 4,886,812 Oct 8, 2010 MIRAPEX Boehringer Ingelheim pramipexole dihydrochloride 4,886,812 Oct 8, 2010 CLIMARA PRO Bayer Hlthcare estradiol;

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The Next Ambien?

Early Monday morning, a decision from the U.S. Food and Drug Administration is expected for yet a whole new type of sleeping pill. It's called Rozerem, from Japanese drug giant Takeda. Rozerem targets the same receptors as the over-the-counter aid melatonin, but with potentially clearer efficacy. (Some have even dubbed it "super-melatonin.") The idea is that by targeting two melatonin receptors in the brain, called M1 and M2, the drug can avoid many of the side effects that are troublesome in other sleeping pills.

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Decoupled moves in Biotech indices highlight opportunities and challenges

The chart below shows returns for the last 6 months of the two Biotech indices that I follow: BTK and NBI.

After a significant and equivalent downside move in March, both indices have turned positive with an explosive move since middle of July. I speculate that the March downside move was a response to concerns over Obama's health care proposal and its impact on Medicare. However, upon further examination, the adjustments in Medicare rebates would translate to no more than a double digit change in revenues. Moreover, the biotech story is in large a product story where launch of a new product has a much higher impact on revenues than any adjustments in rebate system which can be overcome with cost and price adjustments and while keeping healthy profit margins.

The explosive returns in July are rather interesting and may be indicative of things to come. The divergence in the charts of two indices (35% return for BTK vs. 12% for NBI) underlying story of the biotech industry. This trend indicates a value disparity between mid-large cap biotechs and smaller companies. The BTK move can be contributed to recent earnings and product advancement reports coming out of Celgene (CELG), Gilead (GILD), Amgen (AMGN) and other pharma companies that highlight decent earnings growth despite a challenging environment in addition to value added product development successes.

The M&A activity over the last few quarters have just contributed positively to perceived value of these stocks as the recent acquisition of Medarex (MDRX) highlights a larger trend of big pharma acquiring biologics assets and capabilities. This has resulted in speculative run-ups in shares of other companies such as Elan(ELN) and Seattle Genetics (SGEN) who have biologic portfolios. This trend, however, could reverse as rapidly if no new deals are announced in the next few months.

The muted returns in the NBI index highlights the financing concerns that still remain for smaller companies which may cause a wave of consolidations, bankruptcies and asset sales at depressed values.

My favorite large cap names are Genzyme (GENZ) and Amgen(AMGN) and Biomarin (BMRN) and Vertex (VRTX) among mid-sized companies.

Disclosure: The author has no direct stock or option positions in any of the stocks mentioned in this article.

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Multi-species genome comparison sheds new light on evolutionary processes, cancer mutations

In a study published in the July 22 issue of the journal Science, a team of 25 scientists from the United States, France and Singapore compared the organization of the chromosomes of eight mammalian species: human, mouse, rat, cow, pig, dog, cat and horse. Using sophisticated computer software to align and compare the mammals' genetic material, or genomes, the team determined that chromosomes tend to break in the same places as species evolve, resulting in rearrangements of their DNA. Prior to the discovery of these breakage hotspots, the prevailing view among scientists was that such rearrangements occurred at random locations

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Genetic Regulator Of Lifespan Identified

The finding implies that lifespan is not simply dependent on accumulated wear and tear or metabolism, as some researchers have suggested, but is at least partly controlled by an active genetic program in cells--one that could theoretically be boosted. One of the immediate implications of the work is that it emphasizes the functional difference between nicotinamide and nicotinic acid. Nicotinic acid (niacin) is a known anticholesterol treatment, while nicotinamide (or niacinimide) is sometimes touted for anti-aging abilities and is in clinical trials as a therapy for diabetes and cancer. However, the two substances are sometimes sold interchangeably as supplements under the name vitamin B3. "Our study raises the concern of taking high doses of nicotinamide," Sinclair said, because nicotinamide puts a damper on Sir2's actions in the cell

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Curing HIV in Germany?

Every virus-resistant person has two mutant copies of a gene called CCR5, and a new biotech tool called zinc finger nucleases givve anyone that mutation. Instead of transferring bone marrow from another person, doctors could take a few cells from a patient, modify them to be HIV-resistant and then put them back in."

(technology available now from Sigma-Aldrich, CompoZr ZFN)

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DCA "The Cure" for Cancer?

DCA is an odourless, colourless, inexpensive, relatively non-toxic, small molecule. And researchers at the University of Alberta believe it may soon be used as an effective treatment for many forms of cancer.

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MicroRNAs may be key to HIV's ability to hide, evade drugs

The team showed that a cluster of miRNAs bind to a certain location on the viral RNA, which in turn, blocks the creation of important proteins, and HIV replication. Resting CD4 T cells, they found, are “enriched” with more than the normal amount of these miRNAs compared to the activated T cells. When the researchers used antisense technology to block miRNA-caused viral inhibition, they found that the HIV again was active and able to replicate – proving miRNA’s critical role in maintaining latency.

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Pill makes women pick bad mates

Major histocompatibility complex (MHC) genes are involved in immune response and other functions, and the best mates are those that have different MHC smells than you. The new study reveals, however, that when women are on the pill they prefer guys with matching MHC odors. MHC genes churn out substances that tell the body whether a cell is a native or an invader. When individuals with different MHC genes mate, their offspring's immune systems can recognize a broader range of foreign cells, making them more fit. Past studies have suggested couples with dissimilar MHC genes are more satisfied and more likely to be faithful to a mate. And the opposite is also true with matchng-MHC couples showing less satisfaction and more wandering eyes. "Not only could MHC-similarity in couples lead to fertility problems," said lead researcher Stewart Craig Roberts, an evolutionary psychologist at the University of Newcastle in England, "but it could ultimately lead to the breakdown of relationships when women stop using the contraceptive pill, as odor perception plays a significant role in maintaining attraction to partners."

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Genetic Test Predicts Response to Warfarin

That information already is being put to medical use. Last August, the U.S. Food and Drug Administration changed the labeling to say that doctors should consider a genetic test when first prescribing warfarin, better known by its brand name, Coumadin.

But warfarin is a notoriously difficult drug to manage, especially at the start. Too much can lead to hemorrhages; too little can allow clots to form. One individual may do well on 1.5 milligrams a day, while another may require 20 milligrams daily.

Two genes are known to affect the response to warfarin. One, designated CYP2C9, governs the metabolism of the medication, or how fast it is eliminated from the body. The other, designated VKORC1, governs sensitivity, or how the body reacts to a given dose of warfarin. The new study of 297 people starting warfarin therapy showed that variants of the sensitivity gene should be considered in the first prescription, Stein said.

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Patient in Experimental Gene Therapy Study Dies, F.D.A. Says

The case could be another setback for gene therapy, a field with a troubled history and numerous treatment failures, including the death of a teenager in 1999 in an experiment. The new therapy being tested, made by Targeted Gemetics of Seattle, is a virus-based product injected directly in the joints in hope of relieving active inflammatory arthritis. That chronic condition can affect multiple joints and organs, and it is quite different from the wear-and-tear arthritis that commonly occurs with aging. The patient became ill soon after receiving a second injection, the drug agency said. The date is not exactly clear, but the illness was recognized as a “serious adverse event” last Friday, and the agency immediately suspended the study. That means no more injections can be given. The patient died on Tuesday.

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CDC seeing more regular flu cases now

U.S. health officials are seeing a surprisingly high number of cases of ordinary, seasonal flu at a time when the flu season typically peters out.

About half of people recently testing positive for the flu have the new swine flu virus, Dr. Daniel Jernigan of the Centers for Disease Control and Prevention in Atlanta said Friday.

"The H1N1 virus is not going away," Jernigan said. The virus "appears to be expanding throughout the United States" and poses "an ongoing public health threat," he said.

Swine flu continues to affect more younger people — those ages 5 to 24 — and CDC is still seeing relatively few cases in older people

In the United States, there are now more than 4,700 probable and confirmed cases of swine flu, and 173 hospitalizations and four deaths, Jernigan said. The tally doesn't include a fifth death that Texas officials said Friday was due to swine flu

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Multi-species genome comparison sheds new light on evolutionary processes, cancer mutations

In a study published in the July 22 issue of the journal Science, a team of 25 scientists from the United States, France and Singapore compared the organization of the chromosomes of eight mammalian species: human, mouse, rat, cow, pig, dog, cat and horse. Using sophisticated computer software to align and compare the mammals' genetic material, or genomes, the team determined that chromosomes tend to break in the same places as species evolve, resulting in rearrangements of their DNA. Prior to the discovery of these breakage hotspots, the prevailing view among scientists was that such rearrangements occurred at random locations

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California expands newborn test for genetic abnormalities

California now moves to the forefront as it will test for 75 conditions through the standard infant heel prick. That more than doubles the disorders the old test covered. "This is a wonderful day, a great day, where we're not leaving any babies behind," said David Swift, who credits expanded testing with saving his daughter's life. The mandatory screening program will apply to all the 500,000-plus babies born in the state each year, though parents can opt out for religious reasons. Since the state began piloting the program May 2, the tests have identified 15 babies with serious conditions that previously would have gone undetected

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Statin report: Could degrade adults brains

Statins may promote oligodendrocyte lineage commitment by parenchymal glial progenitor cells; this might reduce the available progenitor pool, and hence degrade the long-term regenerative competence of the adult white matter.

GEN News Highlights
Statins affect glial progenitor cells, which are important to brain health as we age, according to a group of scientists. These cells are similar to stem cells and can become either astrocytes or oligodendrocytes. The researchers found, however, that statins caused the glial progenitor cells to turn into only oligodendrocytes.

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Researchers Create First Targeted Knockout Rats Using Zinc Finger Nuclease Technology

In a paper published in the July 24, 2009 issue of Science, researchers describe the novel application of ZFNs to generate rats with permanent, heritable gene mutations, paving the way for the development of novel genetically modified animal models of human disease. ZFN technology will make the generation of such animals faster and will create new opportunities in species other than mice.


"Until now, rat geneticists lacked a viable technique for 'knocking out,' or mutating, specific genes to understand their function," said Howard Jacob, Ph.D. Director of the Human and Molecular Genetics Center at the Medical College of Wisconsin. "This study demonstrates that ZFN technology bypasses the current need to conduct cumbersome experiments involving nuclear transfer (cloning) or embryonic stem cells and allows rapid creation of new animal models."

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The Biologic Revolution

The Biology Revolution

BIOTECHNOLOGY is simply “technology applied on biology”, especially when used in agriculture, food science, and medicine.

Indeed, the modern world went through the “physics revolution” that saw the birth of nuclear power and the “chemical revolution” that lead to the chemical and pharmaceutical industries. And now it is the biology revolution.

Biotechnology now plays a central role in:

>> developing medicine and other therapies
>> understanding diseases
>> forensics
>> improving animal and plant production
>> increasing industry effectiveness
>> environmental monitoring
>> developing alternatives to fossil fuels

Some aspects of biotechnology are very contentious. Genetically modified food, use of animals in research, stem cell development and cloning hog the headlines. These technologies may be unsafe with risks to us or the environment. There are sometimes serious conflicts with society’s beliefs.

Still, biotech is the current buzz and the definite wave of the future. It is seen as the technology to “heal, feed and fuel” the world. There is a huge “biotech war” shaping up globally with much money being poured into this arena.

Malaysia has also plunged into the global marketplace with the launch of the National Biotech Policy on April 28, 2005. The Malaysian Biotechnology Corporation is the facilitator for our biotech ecosystem.

They will also look into creating commercial opportunities; providing funding and industry development services; and advancing research and development and commerce in agriculture biotechnology, healthcare biotechnology and industrial biotechnology. The National Biotechnology Policy is to be implemented in three phases that would eventually see Malaysia as a global biotech player with 20 global icons by 2020.

With India, China and Australia in close proximity as well as Singapore just across the causeway, we have our job cut out for us. For starters, Malaysia is late on the block. That is not necessarily a bad thing. We can learn from the mistakes of others and use it to our advantage.

Focus
Biotech is big. The markets are big. The areas involved stretch from the colours of the rainbow - red biotech (medicine), green biotech (agriculture), blue biotech (marine) and grey biotech (industry). The money involved is big. The rewards are going to be big.

We are a small player moving in late with limited resources. We need to be smart in defining our goals and direction.

Let us use a sport analogy. If Malaysia was aiming for an Olympic gold medal, it certainly would not be in soccer. It should be in badminton or squash. If we are really smart, we should aim to get sepak takraw into the games. It is not sexy but the objective is to hear Negara Ku and see the Jalur Gemilang raised high.

To win in the brutal global marketplace, we will need to ruthlessly focus on our strengths. That would be in agriculture where we can be proud of some successes with palm oil and rubber. If we are focused, we could do a lot more.

Funding
More importantly, we need to develop the needed funding infrastructure – seed finding, debt financing, banks, venture capital, private equity and grants as well as soft loans. Government mandated banks need to get our there and support “green field” projects which are viable. Here we are truly lacking.

It is well known that the gestation period of biotech is longer - certainly longer than in the IT industry. That leads to what is often called the “valley of death”. This refers to the critical period between an inventive idea and an actual product in the market.

Without the necessary funding, many start ups end up dead in the valley. If we are serious about being a global player in biotech, we need to fix financing at home.

Funding entrepreneurs and start ups are very vital in the creation of a new industry. It is companies like these that once created the IT industry in the Silicon Valley.

Malaysia has problems here and needs to strive to solve or minimise it quickly.

Human Capital
To play in the global marketplace and win, we will need world class people to lead world class companies. There is no other way. We have to nurture our best people and be prepared to open our borders to the best biotech brains in research and product development. We will need to collaborate with the best wherever possible anywhere in the world.

Be Efficient
Biotech runs across many different areas. In Malaysia, biotech would involve working with and through half the ministries in the cabinet. This can be a true bureaucracy trap. Many ideas and plans could get unnecessarily stalled (and they do!). We need to be able to rise above that.

Be Accountable
All of us - stakeholders in the industry - need to get together and honestly appraise ourselves. Otherwise, the future of biotech may happen without us.

We have already made a start on April 28, 2005. It is a worthy one.

Let us make it work for future generations, and biotechnology will provide us with a vehicle for wealth generation that will take Malaysia to new heights. If we do it right, future generations will be proud of us.

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Incentives for the Biotechnology Industry

A company undertaking biotechnology activity and has been approved with BioNexus Status by the Malaysian Biotechnology Corporation Sdn Bhd is eligible for the following incentives:

a) 100% income tax exemption for 10 years commencing from the first year the company derives profit, or

b) Investment Tax Allowance of 100% on the qualifying capital expenditure incurred within a period of 5 years and effective from 2 September 2006, a BioNexus status company will be given a concesionary tax rate of 20% on income from qualifying activities for 10 years upon the expiry of the tax emption period. This enhanced incentive from 2 September 2006.

c) Tax exemption on dividens distributed by a BioNeus status company;

d) Examption on import duty and sales tax on raw materials/components and machinery and equipment;

e) Double deduction on expenditure incurred for R & D; and

f) Double deduction on expenditure incurred for the promotion of exports;

g) Effective from 2 September 2006, building used solely for the purpose of biotechnology activities will be an Industrial Building Allowance over a period of 10 years.

2. Incentive for Investment in a BioNexus Status Company

(a) Investment by Parent Company to this Subsiadiary

Effective from 2 September 2006, company that invested in its subsidiary, which is a BioNexus status company, is eligble for tax deduction equivalent to the amount of investment made in that subsiadiary provided that the investing company own at least 70% of that subsidiary.

b) Investment by a Company or Individua; to a BioNexus Status Company

Effective from 2 September 2006, a company or an individual investing in a BioNexus status company is eligble for a tax deduction equivalent to the total investment made in seed capital and early stage financing.

c) Tax Incentives for Mergers and Acquisitions with a Biotechnology Company

A BioNexus status company undertaking merger and acquisition with a biotechnology company is eligble for exemption of stamp duty and real property gain tax within a period of 5 years until 31 December 2011; and

Application should be submitted to the Malaysian Biotechnology Corporation Sdn Bhd.

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Biotechnology, An Instrument of Wealth Creation

BUDGET 2008 offered good news for biotechnology. The government has again demonstrated its commitment to biotechnology as another engine growth.

Malaysia has high hopes for biotechnology. The country wants to deploy biotechnology to add value to the nation’s resources, especially its largely untapped biodiversity. Nearly RM300 million has been set aside to fund various biotech activities.

The will be money for research and development, funding to buy technology, and allocations to promote investment. The Malaysian Biotechnology Corporation (MBC) will anchor programmes to attract investment in biotech.

Already, 36 companies have been given BioNexus status. With that, they enjoy benefits including tax incentives and access to grants for R&D. By the year’s end, the number of BioNexus companies may have doubled. MBC now handles RM100 million in seed funding, loans and others grants to be distributed over five years.

Since the launch of the National Biotechnology Policy in 2005, much has happened. MBC has made good progress in getting the legal, funding and institutional framework in place. Investor interest has started to pick up. InnoBiologics Sdn, Bhd, a Malaysian government-owned biotech investment, has its own RM100 million biopharmaceutical facilities to make generic drugs.

Indications are that the company has been getting many orders to contract manufacture generic drugs. A company from India recently signed a RM7 million deal with the company. Another, also from India, is moving to Malaysia to do stem cell research.

A lot more is needed, however, if biotech is to deliver on its promise to create wealth for the nation. Key stakeholders such as the universities, the business community and investors must come together to germinate new business as well as technology ideas. This is where the country’s technology parks have a role to play.

In Malaysia, Technology Park Malaysia Corporation (TPM Corp), the country’s pioneer science and technology park, plans to allocate more tenancy for biotech companies. A few other S&T parks in the country are also gearing to do the same.

In the decade or so of its existence, TPM has built excellent infrastructure to support the growth of the technology business. It has not been easy.

Attracting the right tenancy to the park has been a major challenge. Companies must have a high-technology element. Notwithstanding the challenges, the park has helped many tenant companies grow from start-ups into highly successful businesses. Several, mainly IT companies, have been listed in the stock market.

But TPM still needs to attract more players to the park. How?

At TPM, new strategies to help enhance R&D commercialisation are being put in place. The park’s Centre for Technology Commercialisation (CTC), for example, will bring key stakeholders together to ideate on R&D and potential business opportunities.

The hope is that business entities development through CTC will eventually constitute the core of the park’s future tenancy. Who knows? They may also provide potential equity opportunities for TPM Corporation.

MBC, on the other hand, has been busy instituting measures-to handle issues of safety and intellectual property.

Very soon, Malaysia will have in place its own Biosafety Bill. This will streamline all the legalities to do with biotechnology. As is true for all investments, there are risks in biotech. It is important to have a clear legal framework if Malaysia is to attract foreign investments in biotech. Only then can risks be evaluated and the necessary mitigation measures taken.

Biotechnology does have its fair share of issues and contro-versies. R&D investment in biotechnology takes a longer time to reach the market. Safety issues have to be adequately addressed through proper legal guidelines.

Then there is the matter of intellectual property. How do we make sure that the IP related to the country’s biodiversity wealth will be local-owned?

We also have to be judicious and selective about which biotech investments to support. There have been instances in the past of Malaysia being preyed on by pseudo-technology companies from abroad bent on making quick bucks. There is no substitute for proper due diligence to avoid such things happening.

Next is the matter of human capital in biotechnology. How can we attract the best talent to biotechnology?

Biotechnology calls for larger upfront investment than IT. Small companies may find difficulty venturing into biotechnology without some initial support. The facilities needed are costly. This is where technology parks can come in and provide shared laboratory and analytical facilities to help especially the small players in the field.

TPM has excellent support laboratories to help new biotech ventures. Together with the technology-commercialisation funding made available by government, there is no reason why new business ideas in biotechnology cannot be nurtured in technology parks for eventual wealth creation.

Author
Dr Ahmad Ibrahim is a Fellow of the Academy of Sciences, Malaysia

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