International news
- AstraZeneca enters into marketing and distribution agreement with MedPointe
- Aventis and Merck begin human trials of HIV prime-boost vaccine
- Aventis reiterates 2003 profit growth outlook
- Aventis Pasteur and NIH enter SARS vaccine R&D agreement
- Eli Lilly and Antares Pharma enter licensing agreement
- Eli Lilly receives FDA request to update product labelling
- Eli Lilly's osteoporosis drug hailed as a breakthough
- Genentech and Graffinity Pharmaceuticals enter R&D collaboration
- Genentech and Protein Design Labs extend Patent Licensing Master Agreement
- GSK announces results of feasibility study
- J&J and Merck receive approval for Pepcid dose increase
- J&J to defend stent market from Boston Scientific
- Schering receives EU approval for lung drug
AstraZeneca enters into marketing and distribution agreement with MedPointe
September 25 – AstraZeneca has entered into an agreement under which MedPointe is responsible for the promotion, sales and distribution of its ZOMIG(R) family of migraine drugs. Until the end of the year the companies will work together on promotion, after which MedPointe will take over. AstraZeneca will retain ownership of the ZOMIG(R) brand and is to continue promotion of the drug family outside the US. The deal provides for an initial four-year term, and is expected to boost MedPointe's profitability and profile in the Central Nervous System marketplace. Net sales for ZOMIG(R) in the US in 2002 were US$177 million.
[Source: Biospace]
Aventis and Merck begin human trials of HIV prime-boost vaccine
September 17 – Aventis and Merck & Co have announced the commencement of human trials to test the safety and immune responses generated by a combination of two anti-HIV-1 vaccine candidates. In an earlier preclinical investigation the combination of vaccines proved more effective than either vaccine used separately. The current Phase 1 study looks at whether these results will be replicated in humans. The trials will investigate a prime-boost regimen that uses Merck's replication-defective adenovirus type 5 vector vaccine candidate first, followed by Aventis' canarypox virus vector vaccine candidate. Volunteers have already received Merck's vaccine candidate in previous clinical trials, and in this study will receive a boost regimen of Aventis' vaccine candidate. Blood samples will be taken and analysed to determine the level of cellular immune reponse generated by the vaccines.
[Source: Business Wire]
Aventis reiterates 2003 profit growth outlook
September 18 – Aventis has repeated its outlook for double-digit profit growth and said sales of its diabetes drug Lantus would exceed half a billion euros this year. Aventis initially made the outlook at the end of the second quarter and sees no reason to change it at this stage. CEO Igor Landau, speaking at the inauguration of a unit to make long-acting insulin Lantus, said the drug would eventually become the company's biggest drug. Aventis now has two units producing Lantus, and expects to open a third some time in the future.
[Source: Reuters]
Aventis Pasteur and NIH enter SARS vaccine R&D agreement
September 29 - Aventis Pasteur, the human vaccines business of Aventis, has entered a R&D agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), to develop an inactivated virus vaccine against Severe Acute Respiratory Syndrome (SARS). Under the agreement, Aventis Pasteur will develop a candidate vaccine using a similar approach to that of the currently licensed inactivated polio vaccine. 'This is important research that could have an impact on public health throughout the world. We hope to be able to advance development of a SARS vaccine by putting to work the knowledge that Aventis Pasteur scientists have amassed in designing inactivated vaccines and the company's expertise in bringing them to market,' said Mr David J Williams, chairman and chief executive officer of Aventis Pasteur. The company expects that it will be at least 2 years until any candidate vaccine moves to clinical trials.
[Source: Company Announcement]
Eli Lilly and Antares Pharma enter licensing agreement
September 16 – Antares Pharma has signed an exclusive licence agreement with Eli Lilly and Company for development and use of Antares' needle-free drug delivery technology in the areas of diabetes and obesity. Lilly also retained an option for application of the technology to one other therapeutic field. Antares will receive an initial upfront payment, plus milestone payments and royalties on end sales of Lilly products using needle-free technology. Under the agreement Lilly also has the option to take an equity position in Antares sometime in the future.
[Source: Antares Pharma]
Eli Lilly receives FDA request to update product labelling
September 17 – Eli Lilly and Company has received a request from the FDA to update labelling on all atypical antipsychotics to include a warning about additional information on hyperglycemia and diabetes. The relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood but epidemiological studies have suggested increased risk. The requested labelling reads: 'Assessment of the relationship between antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population.' The labelling also states that patients who already have diabetes should continually monitor their glucose control while taking the drug.
[Source: Business Wire]
Eli Lilly's osteoporosis drug hailed as a breakthough
September 22 – Eli Lilly's Forteo is the first drug with the potential to reverse osteoporosis, a disorder that thins bone density. The once-daily injection received regulatory approval last November for men and post-menopausal women. By the end of the first half of this year sales reached US$29 million, and are expected to eventually reach up to US$800 million annually. Forteo is the first available drug to actually stimulate new bone formation, and has the potential to cure osteoporosis. Most treatments work instead by stopping or slowing bone loss. Doctors are endorsing Lilly's drug, despite the warning on the label that rats developed bone cancer after taking high doses for most of their lives.
[Source: Reuters]
Genentech and Graffinity Pharmaceuticals enter R&D collaboration
September 18 – Graffinity Pharmaceuticals has announced that it has entered into a long-term R&D collaboration with Genentech for the identification and development of novel small-molecule therapeutics. Under the agreement Genentech will provide a number of drug targets and Graffinity will deliver lead structures for the targets using its RAISE (Rapid Affinity Informed Structure Evolution) technology. Genentech can then either license the programs exclusively or the companies may choose to enter into a joint research program. Graffinity will receive an upfront fee plus research funding and success milestone payments upon delivery of lead compounds. The company may also receive development milestone payments or non-US rights to products resulting from any joint programs.
[Source: Newswire]
Genentech and Protein Design Labs extend Patent Licensing Master Agreement
September 19 – Genentech and Protein Design Labs have agreed to extend their Patent Licensing Master Agreement for an additional five-year term ending December 31 2008. The financial terms of the agreement remain unchanged. As originally agreed, each company may obtain non-exclusive licences under the other company's relevant patents or applications upon payment of a licence fee of up to approximately US$1million per antibody. Genentech and Protein Design Labs are currently in confidential discussions regarding whether or not asthma drug Xolair is covered under the claims of Protein Design Labs' relevant patents.
[Source: Newswire]
GSK announces results of feasibility study
September 16 – GlaxoSmithKline announced the results of a two-part feasibility study of the direct thrombin inhibitor Argatroban combined with the glycoprotein inhibitors at the 15th Annual Transcatheter Cardiovascular Therapeutics meeting. The study found that the combination provided adequate anticoagulation and was well tolerated with an acceptable risk of bleeding in patients undergoing percutaneous coronary intervention. Argatroban is indicated as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia. The multicenter, two-part study involved 152 patients and reported adequate anticoagulation, with the drug being well tolerated by patients.
[Source: Newswire]
J&J and Merck receive approval for Pepcid dose increase
September 24 – The FDA has approved a higher dose of Johnson & Johnson and Merck's heartburn drug Pepcid. The new dose is 20 milligrams, an 100% increase from the normal 10 milligram dose, and will be sold as Maximum Strength Pepcid AC. Approval comes just one week after Procter & Gamble launched an over-the-counter version of competing drug Prilosec.
[Source: Reuters]
J&J to defend stent market from Boston Scientific
September 17 – Researchers have found Boston Scientific's new heart device is effective at treating clogged heart arteries, placing the company in a strong position to rival Johnson & Johnson in the stent market. But chairman of the J&J group, Bob Croce, has announced that the company will meet competition with aggressive sales and pricing strategies, and a line-up of new, easier-to-use products. The results of Boston Scientific's new device are as good as those of J&J's Cypher, which since its approval has been the only drug-coated stent on the US market. The devices are coated with drugs that retard the growth of scar tissue, which often causes the need for re-treatment. Boston Scientific plans to have a competitive stent on the US market by the end of the year, and J&J is already moving to consolidate its market. Results from a head-to-head comparison trial between the two devices are expected in about a year.
[Source: Reuters]
Schering receives EU approval for lung drug
September 23 – German drugmaker Schering has announced that the European Commission has approved its lung drug Ventavis for marketing in all EU countries. The company plans to launch Ventavis in some EU markets later this year, and in the rest of Europe during 2004. The drug is an inhalation treatment for patients with primary pulmonary hypertension, and will have an orphan drug status (an orphan drug is a drug for a disease affecting only a small population) for the first 10 years after approval. Peak annual sales of approximately 50m euros are expected from the drug after three or four years. Schering plans to licence Ventavis to a partner in the US
[Source: Reuters]
