Takeda and XOMA expands Collaboration on Antibody Research

XOMA Ltd and Takeda Pharmaceutical expanded their present research collaboration allowing Takeda with access to multiple antibody technologies, including a suite of research and development technologies and integrated information and data management systems. According to the press release, XOMA will receive a $29 million expansion fee and may receive potential milestones and royalties on antibody products. XOMA may incur an estimated $7.5 million for taxes and other costs related to the expanded collaboration.

Both companies initiated a collaboration in November 2006, whereby XOMA will use its extensive collection of antibody phage display libraries and antibody optimization technologies to discover therapeutic antibodies in multiple therapeutic areas. XOMA’s activities may also include preclinical studies to support regulatory filings, cell line and process development, and production of antibodies for initial clinical trials. Meanwhile, Takeda is responsible for clinical trials and commercialization of drugs after IND submission, and has manufacturing rights once a product enters into phase 2 clinical trials.

The collaboration calls for Takeda to make up-front and milestone payments to XOMA, fund XOMA’s R&D activities including manufacturing of the antibodies for preclinical and early clinical supplies, and pay royalties to XOMA on sales of products resulting from the collaboration. In February 2007, the collaboration was expanded to increase the number of potential therapeutic antibody programs.

“This collaboration expansion is intended to help accelerate Takeda’s corporate goal of building a world class, highly competitive antibody product pipeline by augmenting its already significant in-house capabilities located in San Francisco and Osaka,” said Shigenori Ohkawa, PhD, General Manager of Pharmaceutical Research Division of Takeda. “With the antibody technologies of XOMA, we will further complement our antibody research activities for the creation of new drugs.”

China Aoxing Pharmaceutical receives SFDA approval for injectable drug to treat Ischaemic Cerebrovascular Disease

China-based and US-listed China Aoxing Pharmaceutical Co. Inc. announced that its main subsidiary, Hebei Aoxing Pharmaceutical Group Company, Ltd. has received from China’s State Food and Drug Administration (SFDA) approval for production of Ligustrazine Phosphate Injection for use in the treatment of ischaemic cerebrovascular disease, or ischaemic stroke.

According to the press release, stroke is a silent killer ranked the third leading cause of death in the adult population within China. It also mentions that Ligustrazine Phosphate is an effective intravenous injection drug in hospitals to treat this public heath problem. In a statement made in its press release, Chairman and the CEO of China Aoxing, Juan Yue Han said, “We are very excited to have another injection drug approved for our patients in hospital. This approval further underscores China Aoxing’s long-term commitment to developing high quality hospital care therapies. We are looking forward to launching this product in early 2009.”

A search of the drug brought up several versions of the same drug manufactured by other pharmaceutical companies in China. A picture of a similar product can be seen below.

Ligustrazine Phosphate Injection manufactured by another Pharmaceutical Company in China

It is worth noting, however, that this announcement made by the company was the second after obtaining a production license for Paracetamol and Caffeine Tablets, a controlled substance regulated by the SFDA, a week ago. Paracetamol and Caffeine Tablets are used in China to treat mild to moderate pain, such as headache, migraine, toothache, sore throat, muscular and rheumatic pain, nerve pain (neuralgia), backache (lumbago) and menstrual cramps. The tablets are also effective in relieving aches, pains, sore throat and fever associated with colds and flu.

Products to Aid Smokers Quit sees Sales Growth in Japan

Nicotine patch sales have seen increasing sales growth in Japan after regulations were made less stringent by the health ministry early this year, allowing smokers to buy such products over the counter. Novartis Pharma K.K., a unit of Swiss drug giant Novartis AG, started selling Nicotinell patches in Japan in May while other companies followed suit last summer. Japanese pharmaceutical companies like Takeda Pharmaceutical Co. launched Johnson & Johnson’s Nicorette Patch, while Taisho Pharmaceutical Co. released Ciganon CQ, a product co-developed with GlaxoSmithKline PLC of Britain.

Taisho's Ciganon® CQ, Picture from Taisho's Official Photo

Nicotine patches are applied on the skin by smokers, allowing the release of nicotine into the body through the skin and is one of the methods used to quit smoking. Prior to the relaxation of regulations, nicotine  patches required doctor’s prescription in Japan until it was allowed to be sold as an OTC drug.

It is estimated that the market for products that help to quit smoking in Japan grew 2.5-fold in the 3 month from June to August compared the same period a year before, with the main contribution from strong sales of skin patch products, according to Novartis. Other than nicotine patches, chewing gum type products are also attracting strong demand as some smokers prefer chewing gum that helps users to relax by providing an alternative to cigarettes that is consumed orally.

It is forecasted that this market is expected to keep attracting interest in the face of increasing pressure on smokers by the government in Japan, including a possible tobacco tax increase.

Dr Reddy’s Launches Inhalers for Asthma Patients in India

One of India’s foremost pharmaceutical manufacturer, Dr Reddy’s Laboratories, which is listed in NYSE, has launched the Combihale™ and Redihaler™ product lines in India, marking its entry into the inhaler market for asthma patients. The Combihale™ is a combination of a steroid and a long acting bronchodilator and would initially be available in two combinations, the Combihale™ FF (Formoterol + Fluticasone) and Combihale™ FB (Formoterol + Budesonide). 

Picture of Combihale™ from Dr Reddy’s website.

In addition, the Combihale™ would be supplied in a package with the Redihaler™, a dry powder inhalation device that was designed in-house by the company. This is expected to be the promotional offer as the Combihale™ range of drugs could be dispensed under the option of dry powder (DPI) or metered dose inhaler (MDI) format. According to the press release by the company, the inhaler market in India is valued at Rs 473 Crores (4.73 billion Rupees or approx US$100 million) and forecasted to grow at a rate of 17% annually. Given the increasing number of patients and the burgeoning middle class in India, the entry into the consumer market is a good time for the company.

US Patent for Molecular Toxicology awarded to Ocimum Biosolutions

Hyderabad-based, Ocimum Biosolutions, a leading integrated genomics company based in India has been awarded US patent No US 7,415,358 B2 entitled ‘Molecular toxicology modeling’. The patent describes elucidation of the global changes in gene expression and identification of toxicity markers in tissues or cells exposed to a known renal toxin. This invention covers a database of genes characterized by toxin-induced differential expression that is designed for use with microarrays and other solid phase probes. The genes have applications as toxicity markers in drug screening and toxicity assays. 

Chief Executive Office of Ocimum Biosolutions, Anu Acharya, commented that the company consistently been in the forefront of Genomics Innovation over many years and that this patent has reinforce their objective of continuing to be a leading player in the area of integrated genomics. The CEO also added that Ocimum will continue to pour in resources in areas like Genotyping, Gene Expression, PCR and other data validation methods so as to provide the latest technologies for their pharmaceutical and biotech clients.

The patent granted to Ocimum is expected to increase the company’s prestige in the areas of pharmaceutical outsourcing.

New drug Hotmin® offered by Eisai to Improve Peripheral Blood Circulation

One of Japan’s largest pharmaceutical company, Eisai Co. Ltd. is scheduled to release a new over-the-counter drug named Hotmin. According to the company’s press release, the new drug was designed to improve the peripheral blood circulation, and hence relieving symptoms of coldness in extremities and stiff shoulders.

With the product being mainly catered to women, as they tend to have poorer peripheral blood circulation than men due to differences in physical structure, Eisai have conducted a survey in Japan that more than half of the women in their 20s and 30s suffer from some kind of coldness in the extremities and/or suffer from stiff shoulders.

The new drug is to be sold in a tablet form, an taken orally and contains 3 main active ingredients: nicotinic acid in helping to dilate the peripheral vessels, ginseng extracts to increase blood flow, and d-alpha tocopherol succinate (a natural-type vitamin E). Through improving peripheral blood circulation, the drug is expected to optimize the delivery of oxygen and nutrients throughout the body, and assist in dispersing heat produced in the muscles around the body which will in turn relieve the symptoms of coldness in the extremities and stiff shoulders amongst women.

Picture from Eisai Co. Ltd.

Bayer Consumer Care Division adds Topsun’s Western OTC Cough and Cold Portfolio

Bayer Healthcare made a press release today, stating that its subsidiary, Bayer Healthcare Company Limited in China have obtained the required regulatory approvals for the acquisition of the Western over-the-counter (OTC) cough and cold portfolio of Topsun Science and Technology Qidong Gaitianli Pharmaceutical Co. Ltd. Bayer will pay a total of RMB 1,072 million (around US$ 156 million) with an additional of RMB 192 million (around US$ 28 million) subject to fulfillment of certain performance criteria. Topsun’s OTC cough and cold portfolio includes White and Black, a leading brand in an important consumer healthcare category.

Through this acquisition, Bayer will increase its presence in China, which has a rapidly growing OTC market. All personnel and assets related to the acquired business, including the Gaitianli manufacturing plant in Qidong City, Jiangsu Province as well as the national sales force and distribution network will be transferred to Bayer Healthcare, to operate within the Consumer Care Division.

Commenting on the acquisition, Arthur Higgins, Chairman of Bayer HealthCare said, “With this transaction Bayer HealthCare follows its global strategy to invest in and grow in emerging markets such as China, one of the most dynamic OTC markets in the world.”

Daiichi Sankyo to purchase majority stake in India’s Ranbaxy

Japan’s third largest pharmaceutical company, Daiichi Sankyo is set to purchase up to 50.1% of India’s largest pharmaceutical company, Ranbaxy for as much as $4.6 billion. The company agreed to buy the entire 34.8% held by Ranbaxy’s billionaire Chief Executive Officer Malvinder Singh and his family and a portion of about $1 billion of preferential stock that Ranbaxy will issue. The sale will trigger a mandatory offer for 20 percent more from shareholders under Indian takeover rules.

This move represents Daiichi’s strategy to enter the generic-drug market where sales are growing twice as fast as branded medicines. By acquiring Ranbaxy, Daiichi would be closer to break into the top 10 companies in the $120 billion generic- pharmaceutical market, which grew 11.0% last year, compared with 6.0% for all drugs. This acquisition is Daiichi’s second one within 2 months after acquiring a German biomedical firm in April this year.

Riken moves forward with research on Alzheimer’s

A team from the Laboratory for Proteolytic Neuroscience at RIKEN is conducting extensive research on Alzheimer’s disease, specifically focusing on the study of somatostatin, a neuropeptide that inhibits the secretion of growth hormones. This research in intended to lead to the discovery of new medicine for Alzheimer’s disease.

Alzheimer’s disease is a cognitive dysfunction disorder that occurs when nerve cells are impaired and and thus affects brain activity. There are around 24 million Alzheimer patients worldwide. Amyloid peptide has been identified as the pathogen that exhibits neurotoxicity and consists of 42 amino acids which are produced in the brain. The disease occurs when amyloids peptides accumulate in excess outside of the nerve cells.

The Researchers at Riken also discovered that Neprilysin, which breaks up amyloid peptide, diminishes with age and decreases even further upon the onset of Alzheimer’s disease.

In the laboratory, they treated an Alzheimer’s disease model mouse with a gene therapy that boosted the activity of Neprilysin by 10 times, and as a result, were able to suppress the accumulation of the amyloid peptide.

Riken is currently conducting bio-chemical and histological analysis of the brain using an Alzheimer’s disease model mouse.

For video footage, please visit
http://movie.diginfo.tv/2008/06/05/08-0240-gm-en.php

Daiichi Sankyo makes German acquisition

Japanese pharmaceutical firm, Daiichi Sankyo Co., Ltd. has entered into an agreement to acquire privately held German biotechnology firm, U3 Pharma AG, whose focus is on the research of antibodies for the treatment of cancer.

Daiichi Sankyo will purchase all the stock of the U3 Pharma and make a one-time payment of 150 million Euros (US$235 million) for the company. U3 Pharma, which is based in Martinsried, Germany, was founded by Professor Axel Ullrich of the Max Planck Institute of Biochemistry, whose pioneering gene technology-based and oncology-focused research led to the development of the oncology blockbusters Herceptin and Sutent. The company was established in 2001 and currently employs 27 people, the majority of whom work directly in research and development. Some of U3 Pharma’s shareholders includes Alta Partners, Atlas Venture, E. de Rothschild Investment Partners, Life Science Partners and Karsten Henco amongst many other private individuals from the biotech and pharmaceutical industries.

U3 Pharma has in its pipeline a range of unique therapeutics program that focuses on fully-human antibodies as potential therapies for breast, lung and colorectal cancers, among others. The company’s leading product, which is being co-developed with Amgen, is U3-1287 (AMG 888), the first fully-human anti-HER3 monoclonal antibody (mAb), to inhibit oncogenic signaling and tumor proliferation. The companies intend to initiate clinical development of this compound this year.

It is worth noting that Daiichi Sankyo has the commercial rights to sell and distribute denosumab, or AMG 162, licensed from Amgen in Japan only. For more details on the press release, please go here.