Biopeer

Significant advances in drug delivery

British researchers have pioneered a novel way to administer life saving drugs into the heart muscles of patients suffering from a severe form of heart failure. The researchers tested the technique on 15 patients whose heart failure necessitated implantation of an assist device. In this technique, the researchers administered a combination of pharmaceutical therapies including beta blockers, ACE inhibitors and the drug clenbuterol through a left ventricular assist device. This is a pump that performs the function of the left ventricle when the chamber is unable to do so any longer. The success of the treatment is evident in the fact that it aided the removal of the device in 11 of the patients and there were nine survivors at the end of four years.

Meanwhile, researchers from the University of Calgary have determined that the efficacy of the cancer fighting vesicular stomatitis virus (VSV) increases when it is given intravenously instead of directly into a tumor. The findings came as a result of a study on mice and tumor specimens. The researchers, led by Dr Peter Forsyth injected VSV intravenously into the mice. They found that it effectively spread and attacked multiple areas of the tumor. They accept that these are very early results but are hopeful that further tests would yield just as encouraging results.

An American company, Perfusion Technology claims to have achieved a possible breakthrough in the fight against brain tumor. The firm has developed a device that can open the blood brain barrier (BBB) using low-intensity ultrasound technology. This is a significant achievement as breaching the barrier will help therapeutic drugs reach the brain directly, thus leading to more effective treatments. As opposed to the current methods to breach the barrier, this is non-invasive and easy-to-use.

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New alliances for developing diabetes products

Two major pharmaceutical companies have separately entered into agreements that will see them take a major step into the field of diabetes drugs.

The drug delivery technology maker Nastech Pharmaceutical Co announced its pact with drug maker Amylin Pharmaceuticals Inc to develop a nasal spray for diabetes. The main ingredient in the spray will be exenatide. Preclinical studies of the formulation show positive results and preparations are underway for commencing studies to verify its feasibility in human subjects. The drug will be developed by Amylin and marketed by Nastech. Nastech will also receive the royalty and milestone payments from the end product. Through the collaboration, both companies aim to provide therapeutics that facilitate a healthier life. The announcement lead to Nastech shares rising to USD 15.38 in afternoon trading on the Nasdaq, while Amylin shares rose up to USD 46.87.

Meanwhile, Metabolex, Inc has decided to address metabolic diseases in collaboration with Ortho-McNeil, Inc, a Johnson & Johnson company. The focus will be on type 2 diabetes, obesity and dyslipidemia. Metabolex's two clinical compounds, metaglidasen and MBX-2044, and additional follow-on compounds are included in the agreement. The two companies will work together to screen metabolic disease targets identified by Metabolex. According to Harold E Van Wart, Ph D, President and CEO, Metabolex, the deal will aid the development and commercialization of its lead best-in-class type 2 diabetes products and will also enhance the company’s capability to produce future first-in-class therapies. The contract will equip Metabolex with USD 40 million in equity and convertible financing.

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Indo-Italian initiative on drug discovery

Global technology services major Tata Consultancy Services Ltd (TCS) has entered into an agreement with Congenia, a biotechnology start-up promoted by Italy’s Genextra SpA Group, to provide advanced fragment-based lead optimisation solutions for drug discovery.

Under the pact, TCS’ Life Sciences R&D Division would work on ‘P66’, a target protein identified by Congenia as a key protein involved in several age-related diseases, and develop optimised drug leads based on it. Using modules of its own indigenised software ‘Bio-Suite’ to work on the target protein, TCS would screen a ‘virtual fragment library’ of potential lead molecules to predict which of these might bind themselves to the target protein and thereby inhibit its function. TCS would also produce a first-cut analysis of the ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) profile of the lead molecules. Congenia will further develop the optimised lead molecules produced by TCS through animal trials and eventually human clinical trials.

Increasing costs of discovering new drugs and taking them to the market puts the average cost of discovering a new drug at about one billion dollars. A large portion of this cost results from the failure of drug candidates at various stages of testing. Presently, a great deal of drug discovery especially in bio-pharmaceuticals consists of simply trying out all possible combinations of proteins and drug candidates and putting them through high throughput screening. The use of IT solutions in the drug discovery process will allow pharmaceutical companies to eliminate many combinations at the simulation stage itself. This would not only mean a significant reduction in cost of drug discovery, but would also cut down on the time to market of much-awaited blockbuster drugs.

Facing the R&D Challenge

Dr. Jacques-Pierre Moreau,executive vice president and chief scientific officer of Ipsen, a European pharma company, wrote an interesting opinion piece recently on the challenge facing pharma, especially in regards to R&D.  His main points are below:

• Ensure excellence in all aspects of research and development: discovery of new molecules, formulation innovation, process development, pharmacology, state-of-the-art preclinical and clinical development and regulatory strategies. At all stages of the R&D process, trust intuition as much as the textbooks letting human inquisitiveness and ingenuity express itself.
• Attract and nurture talented and dedicated people to contribute to the R&D effort. To bring company processes to world-class standards, professional development experts will be in high demand. But their technical skills should not overshadow the need for reactivity and constant adaptation to an ever-changing environment
• Forge long-standing partnerships. Combine the commitment to high-quality, in-house research with a proactive partnership policy involving collaboration with academic institutions, large pharmaceutical companies and biotechnology firms to achieve the most positive results.
• Institute innovative and revolutionary technologies taking advantage of the fallout from the elucidation of the human genome sequence. The traditional method of discovering or developing new drugs is becoming obsolete and instead, an irreversible path has opened up whereby the use of emerging molecular diagnostic and prognostic tests will allow initial testing and later commercialization of products to those patients likely to benefit most from specific treatments.

From: Pharma companies must shift focus to R&D efforts

Many of these suggestions are excellent, the cynic asks, will managers buy it.  Pipelines are being squeezed and the pressure on researchers is tremendous.  It comes down to the old can we afford not to try something different.  Technology, no matter how fast computers get, will not solve the whole problem.  A deep culture of research, a passion for science, for finding innovative ways to both solve and pose questions.  These are the keys.  The problem is, people have to do this, and often people don't.

 

 

 

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