The Andhra Journal of Industrial News
(An International Electronic Digest Published from the United States of America)
(dedicated to Andhra, My Mother's Homeland)

Chief Editor: Prof. Sreenivasarao Vepachedu
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Issue 64

5111 Kali Era, Virodhi Year, Ashada month
2067 Vikramarka Era, Virodhi Year, Ashada month
1931 Salivahana Era
Virodhi Year, Ashada month
 2009 AD, July





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Biologic Exclusivity
A U.S. Senate committee decided to give the biologic drugs 12 years of market exclusivity, despite populist and short-sighted efforts by opponents to limit the exclusivity at 5 or 7 years.   This is a limitation that didn’t exist before and there was no path for biosimilars’ approval thus far.  The sale of generic versions of most brand-name medicines is permitted after patent/market exclusivity expires, but not complex biotech drugs. This measure, which passed 16-7, calls for the sale of lower-cost generic versions of the complex drugs, 12 years after the FDA approves the brand-name version.
The 12-year limit still needs approvals from the full Senate and the House.

Exclusivity refers to years of sales that a brand-name product gets before a lower-cost generic or an improved product that relies on the brand-name data can be approved by the Food and Drug Administration. It is separate from patent protection, but runs concurrently. Generic-drug makers would have to wait for both to run out before marketing their products.

Current US laws, which provide for generic competition on chemical pills, don’t allow for cheaper copies of complex drugs made from living cells, because they are very difficult to replicate and dangerous, unlike small-molecule chemical pills. So, at present there is path for generic approval for vaccines and antibodies.

Large molecule biologics, such as vaccines and antibodies, are grown in living organisms, such as cells or animals. Almost any difference in the cell line or growth conditions can alter the resulting protein product, particularly since its biological effects depend on glycosylation and other post-translational modifications, as well as on the protein's amino acid sequence. Different placement of a single carbohydrate can cause the biologic to react completely differently in the body. Aside from allowing more time for competitors to test their follow-on products for safety and efficacy, the longer period gives the original maker a longer time to earn profits after spending hundreds of millions of dollars on research and development.  The expected average cost of an approved biologic is about $1.2 billion. 

In general, most countries outside the US and Europe allow copies after five to seven years of exclusivity and do not develop any new drugs.  India doesn’t allow any market exclusivity and, no new branded products have been marketed in India or outside of India, by the indian indigenous industry so far.  In the US, where there is a strong patent regime, patents will give biotech companies more protection than any of the bills now in circulation.  However, patent protection is 20 years from filing date of a patent application, and most of it is wasted during the development of the drug, clinical trials and FDA approval process.  

In Canada, under the regulations, an "innovative drug" that contains a medicinal ingredient not previously approved in a drug by Health Canada is entitled to an eight-year term of data protection. This term can be extended for an additional six months for pediatric population submissions. If a subsequent manufacturer seeks approval of its product on the basis of a direct or indirect comparison with an innovative drug marketed in Canada, the manufacturer 1) may not file its drug submission for six years; and 2) will not receive marketing authorization for eight years (or eight years and six months) from the date that the innovative drug was approved for sale.

The Canadian Guidance on Data Protection indicates that this prohibition (data exclusivity for 8.5 years) will apply to a new drug submission for Subsequent Entry Biologics (SEBs) or so called biosimilars where approval is sought on the basis of a comparison to an innovative drug. The two key features in an SEB submission are 1) a comparison to a reference product, and 2) a reduced data requirement due to reliance on data previously generated for the reference product by the innovator at high cost.  Furthermore, Health Canada intends to amend the Guidance on Data Protection to confirm that data protection extends to an innovative drug when it is indirectly compared to an SEB by virtue of a foreign reference product. As for patent protection, when a non-Canadian reference biologic is substituted for the Canadian product and a link is established to a drug marketed in Canada, this would be considered a comparison that would trigger the data protection regime.

Several Canadian patents covering biologics have either recently expired or will expire shortly; numerous SEB approvals are thus expected in the coming years. Health Canada has indicated that a number of SEB submissions are pending and so the industry is bracing for the arrival of additional SEBs into the Canadian marketplace.

Drug Discovery: How it Happens - A Discussion:
Drug Approval Statistics:

Johnson & Johnson Buys Elan
Johnson & Johnson agreed to pay $1 billion for a stake in Elan Corp. and will develop the Irish drugmaker’s medicines against Alzheimer’s disease.  J&J has one Alzheimer’s drug, Razadyne, which generated $541 million in sales last year. Eli Lilly & Co. has two drugs in late stage testing, an antibody treatment that would compete with bapineuzumab, and a type of compound called gamma secretase inhibitor. Bristol-Myers Squibb Co. is also working on a gamma secretase inhibitor in early human testing.  The deal with Elan gives J&J “access to a late-stage, first-in-class drug that has the potential to delay disease progression for Alzheimer’s patients.

The Alzheimer's Immunotherapy Program (AIP) is a collaboration between Elan and Wyeth to research, develop, and commercialize immunotherapeutic approaches that may be used to treat and possibly prevent the onset of Alzheimer's disease. The AIP is committed to researching the burden of care and cost of AD as well as developing tools that help advance these efforts. The AIP is also currently conducting clinical trial enrollment throughout Europe and the United States for its lead investigative compound bapineuzumab.

Also, Johnson & Johnson has bought Cougar Biotechnology, which has a pipeline focused on oncology, for almost US$1 billion. The company's lead compound is abiraterone, an inhibitor of cytochrome P450 17 (CYP17), an enzyme involved in androgen and oestrogen biosynthesis, which has recently shown positive Phase II results in castration-resistant prostate cancer (CRPC).

Sanofi Buys Shantha
Sanofi-Aventis SA, France’s biggest drugmaker, agreed to take control of Shantha Biotechnics in an acquisition valuing the Indian vaccine maker at 550 million euros ($784 million).  Under terms of the agreement, Sanofi’s vaccine unit will buy ShanH, which owns 80 percent of Shantha Biotechnics, from the Merieux Alliance, Paris-based Sanofi said in a statement. The French drugmaker is paying about 440 million euros for the purchase. The transaction is set to close before the end of the third quarter, Sanofi said.  The purchase gives Sanofi a platform in India as well as access to Shantha’s pipeline of new products, including an experimental typhoid vaccine. Prior to this acquisition, Sanofi’s Indian operations had a total of 2,870 employees, mostly based in Mumbai. Shantha brings in the low-cost production facilities that ease access to emerging markets.  Sanofi Pasteur, the French drugmaker’s vaccine unit, will support Shantha’s development. Varaprasad Reddy, who founded the Indian vaccine maker in 1993, will continue leading Shantha as managing director.

Hyderabad-based Shantha is expected to have sales of about $90 million for the current fiscal year, Sanofi said. Shantha was the maker of the first recombinant Hepatitis B vaccine produced in India in 1997 and the maker of numerous combination vaccines.  Shantha’s drugs under development were of particular interest to Sanofi-Aventis. These include: rotavirus vaccine, conjugated typhoid vaccine, and human papilloma virus vaccine.  The deal is a sign of increased international interest in the India biotech sector.  Sanofi-Aventis has in the past few months completed the purchase of smaller generic drugmakers in Czech Republic, Mexico and Brazil, as well as Zentiva, which has operations concentrated in eastern Europe and Turkey.  Most recently, Sanofi-Aventis agreed to pay $500 million for Brisbane, California-based BiPar Sciences, which is working on a new cancer treatment.  According to a report Sanofi-Aventis will set aside 30 billion euros over three years for acquisitions. 

GlaxoSmithKline, the UK-based pharmaceutical group, recently agreed a series of licensing deals with generics drugs producers in India and South Africa. Pfizer, the world's largest pharmaceuticals group, has also agreed partnerships with two Indian generic groups currently involving no equity stake.

Bristol-Myers Squibb Company and Medarex, Inc Merge
Bristol-Myers Squibb Company and Medarex, Inc. announced in July that the companies have signed a definitive merger agreement providing for the acquisition of Medarex by Bristol-Myers Squibb, for $16.00 per share in cash. The transaction, with an aggregate purchase price of approximately $2.4 billion, has been unanimously approved by the boards of directors of both companies. Medarex’s projected $300 million in net cash and marketable securities at closing would be an asset acquired by Bristol-Myers Squibb resulting in an implied purchase price of approximately $2.1 billion.  Acquires Proven Antibody Discovery Technology. Gains Full Rights to Promising Phase III Compound, Ipilimumab. Significantly Expands Oncology and Immunology Pipeline. Medarex’s UltiMAb Human Antibody Development System®, which produces high affinity, fully human antibodies for use in a broad range of therapeutic areas, including immunology and oncology. This validated technology platform has produced compounds which are now currently marketed therapies (SIMPONI™, STELARA™ and ILARIS®). Medarex’s next-generation Antibody-Drug Conjugate (ADC) technology, which is a novel and proprietary platform that could open new fields in oncology drug development. Rights to seven antibodies in clinical trials under Medarex’s sole sponsorship and three other antibodies being co-developed with other partners. Rights to pre-clinical assets in various stages of development by Medarex -- in particular, monoclonal antibodies focused in oncology and immunology.

Genentech/Roche has taken 156,000 square feet of space at 500 Forbes Blvd., formerly occupied by Cell Genesys in South San Francisco, and is reportedly on the hunt for more. Roche is closing manufacturing and cutting back-office jobs in Nutley, N.J., letting loose more than 1,300 people in the process. Roche is well on its way to shuttering its research facility in Palo Alto, shifting hundreds of positions to South San Francisco and New Jersey, while another 500 or so flat-out lose their jobs.  Many biotech firms are tightening the belt these days - Amgen, Affymetrix, Celera, Nanogen, Life Technologies, Elan etc are all laying off.

Thousand Oaks-based Amgen laid off about 100 employees on July 22.  The most recent round of cuts was among the company’s clinical manufacturing and quality-control workers. Previously, on May 1, Amgen laid off about 100 workers as part of an outsourcing of the company’s facilities services group.  Amgen has steadily reduced its workforce since hundreds of layoffs were announced in the summer of 2007. The most recent cuts are part of the company’s ongoing evaluation of staffing levels.  

Celera also nnnounced cost-saving measures, which include a restructuring program to reduce headcount by approximately 13%.

Source: The primary sources cited above,  BBC News, New York Times (NYT), Washington Post (WP), Mercury News,, Chicago Tribune, CNN, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP,  Biospace etc.

Notice: The content of the articles is intended to provide general information. Specialist advice should be sought about your specific circumstances.

Copyright ©1998-2009
Vepachedu Educational Foundation, Inc
Copyright Vepachedu Educational Foundation Inc., 2009.  All rights reserved.  All information is intended for your general knowledge only and is not a substitute for medical advice or treatment for special medical conditions or any specific health issues or starting a new fitness regimen. Please read disclaimer.

Om! Asatoma Sadgamaya, Tamasoma Jyotirgamaya, Mrityorma Amritamgamaya, Om Shantih, Shantih, Shantih!
(Om! Lead the world from wrong path to the right path, from ignorance to knowledge, from mortality to immortality and peace!)
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