Biotechnology news from around the world.
- AstraZeneca continues to succeed with Prilosec... for now
- Bristol-Myers' schizophrenia drug wins conditional approval
- British Biotech in merger talks with rival
- Genentech's breast cancer drug disappoints
- Novartis to buy generic manufacturer
- UK to develop stem cell bank
- US FDA to change drug review; develop new guidelines
- WHO head to stand down
AstraZeneca continues to succeed with Prilosec... for now
7 September – Despite losing its main US patent protection 11 months ago, AstraZeneca continues to obtain significant revenues from its ulcer drug Prilosec. An important factor contributing to this success is that the company has used several additional patents, which describe the way the drug is made. These patents have effectively stopped generic competitors from marketing rival versions of the drug. Yet, a New York judge is soon to decide whether AstraZeneca can remain the exclusive seller of the drug. If it loses, it will have to face generic competition for Prilosec, as is already the case in Europe (where it is sold as Losec) and Australia. Depending upon the technicalities or ambiguities in the judgment, however, the company may still be able to maintain some market exclusivity – with smaller generic firms not wanting to risk being sued.
[Source: Reuters – Ben Hirschler]
Bristol-Myers' schizophrenia drug wins conditional approval
3 September – Bristol-Myers Squibb, together with Otsuka Pharmaceutical Co, have received a conditional approval from US regulators for their experimental schizophrenia drug, Aripiprazole. The FDA has issued the companies with an 'approvable letter,' indicating the drug has satisfied most of the requirements for approval. In clinical studies of the drug, patients suffered only minimal side effects, typically seen in such a medication. This 'clean' safety profile suggests the drug could become very popular upon commercial release. Once approved, the companies plan to market the drug under the brand Abilify.
[Source: Reuters]
British Biotech in merger talks with rival
9 September – In line with a growing trend towards European biotech consolidation, British Biotech and Germany's MorphoSys have entered early merger talks. British Biotech is presently one of the few cash-rich companies in the sector. However, the company is seeking a partner with a sound technology platform, following the failure in recent years of several of its own product developments (including the cancer drug Marimastat). MorphoSys is being targeted by British Biotech because the company has several development candidates in the both cancer and anti-infectives. It has also developed a library of synthetic antibodies, for potential use as novel drugs. At this stage, British Biotech has confirmed that talks are taking place, but has advised shareholders not to take any action.
[Source: Reuters – Santosh Menon]
Genentech's breast cancer drug disappoints
9 September – Genentech has revealed disappointing results from a Phase III clinical trial of its experimental breast cancer drug, Avastin, designed to inhibit the formation of new blood vessels to tumours to inhibit their growth. When combined with another medicine, the drug has failed to effectively treat relapsed metastatic breast cancer patients. Announcing the results, Genentech indicated Avastin did not meet a primary efficacy point of progression-free survival, although some statistically significant responses were observed. The drug is, however, still involved in Phase III studies for colorectal cancer.
[Source: Reuters]
Novartis to buy generic manufacturer
29 August – Swiss drug firm Novartis AG is to buy the Slovenian generic drug company, Lek. The takeover plan, with a price of US$886m cash, will give Novartis a new role in generic drugs in Eastern European markets. One notable capacity Novartis will gain is the capacity to manufacture a generic version of GlaxoSmithKline's popular antibiotic Augmentin. Lek also recently received US FDA approval for its production facilities. Under the deal Novartis' sales of generics will also be boosted, to around US$1.5bn annually.
The offer currently remains conditional upon Novartis receiving acceptances for at least 51% of Lek's share capital and the approval of certain conditions.
[Source: Associated Press]
UK to develop stem cell bank
28 August & 10 September – Britain's Medical Research Council (MRC) is to develop a human stem cell bank. The bank will collect adult, embryonic and foetal stem cells, for subsequent use in approved medical research. To be operational within a year, the bank will be operated by the National Institute for Biological Standards and Control, which has won a ₤2.6m contract to establish the facility at its Hertfordshire laboratories. Researchers will then be granted access to the cells, pending the approval of their research by a steering committee. Fertility experts have issued caution over the bank, citing the need to ensure that couples involved in IVF treatment do not feel coerced to donate 'spare' embryos to the bank. Yet the country's Human Fertilisation and Embryology Authority (HFEA) reassures those concerned that there are adequate guidelines in place to protect patients.
[Source: BBC News Online, Reuters]
US FDA to change drug review; develop new guidelines
6 & 9 September – The US Food and Drug Administration is to alter the review process for drugs derived from living organisms, moving them to the same unit that handles chemical-based medications. The move, intended to speed up the approval process, has been praised by biotechnology companies. Both kinds of medications will now be handled by the FDA's drug unit, which has halved its review process time over the past decade. In contrast, the biological division (where drugs from living organisms are now reviewed) has increased its review process times. The move is also hoped to provide consistency on the review processes for the two types of drugs. Under the new regime, the biological division will retain control on the regulation of vaccines and blood products.
The FDA has also released new guidelines, which list what is required by drug developers when proving the safety and efficacy of drugs made from bioengineered plants – that is, plants manipulated using genetic technology to produce drugs. This process promises to be cheaper than manufacturing drugs, with several drugs now being tested prior to sale in the US. Under the guidelines, the plants that are chosen to produce the drugs should not contain allergic compounds, and should not spread easily. If the plant being used is also a food source, steps must be taken to ensure the bioengineered plant cannot reach food supply chains.
[Source: Reuters – Kim Dixon; USA Today – Elizabeth Weise]
WHO head to stand down
31 August – After only one term, the Director-General of the World Health Organisation, Dr Gro Harlem Brundtland, is to stand down. This is the first time a WHO director general has not held office for at least two consecutive terms.
[Source: BMJ]