Harbinder Virdi

Danish LEO Pharma has gained additional ground in the US after finalising the agreement to acquire Australian-US Peplin, Inc. It was announced that Peplin, Inc and LEO Pharma A/S have completed their definitive merger agreement after obtaining the approval of the majority of stockholders as well as completing the relevant regulatory activities. The deal was originally announced on 3 September, 2009 when LEO, a privately-held, leading global pharmaceutical company within Dermatology and Critical Care, agreed to acquire all outstanding securities of Peplin for approximately USD 287.5 million in cash. Peplin will operate as a US-based LEO subsidiary with George Mahaffey, formerly Peplin's chief commercial officer, promoted to lead the company as chief executive officer.

Abbott announced a definitive agreement to acquire the global rights to PanGenetics BV's PG110 fully humanized antibody to Nerve Growth Factor (NGF), expanding the company's pain care portfolio and leveraging its expertise in biologics. PG110 is a novel biologic in phase-I clinical trial development that targets NGF for the treatment of chronic pain. NGF is released at sites of tissue damage and inflammation, and plays a significant role in the transmission of pain signals by the central nervous system.

Novartis announced the availability of Prevacid 24HR (lansoprazole delayed-release capsules 15 mg/acid reducer) over-the-counter in pharmacies and retail stores across the US to treat frequent heartburn. Prevacid 24HR received US Food and Drug Administration (FDA) approval in May 2009. It is the first and only over-the-counter (OTC) Proton Pump Inhibitor (PPI) for the treatment of frequent heartburn in its original formulation.

Endo Pharmaceuticals has reached a settlement with LecTec Corporation on outstanding patent litigation related to LecTec's US Patent Nos. 5,536,263 and 5,741,510. Endo Pharmaceuticals has agreed to make a one-time, US$ 23 million payment for the exclusive license to these two patents for use in the field of prescription pain medicines and treatment. "We are pleased to add these patents to our IP inventory especially as they relate to Lidoderm," said Caroline Manogue, executive vice president and chief legal officer of Endo Pharmaceuticals.

Simcere Pharmaceutical Group, a developer of branded generic and proprietary pharmaceuticals, has signed an agreement to acquire the manufacturing license in China of rosuvastatin from Tianjin Tianda Pharmaceutical. The acquisition of the manufacturing license will be effected through the acquisition of equity in Tianda as well as transfer of certain technologies from Tianda. Rosuvastatin was first marketed by Astrazeneca as Crestor in 2003 and is an effective statin to treat high cholesterol and related conditions, said Simcere. Upon completion of the acquisition, Simcere will start manufacturing rosuvastatin.  

Caraco Pharmaceutical Laboratories, a developer of generic and private-label pharmaceuticals, has launched ketorolac tromethamine ophthalmic solution, 0.5% following a final approval from the FDA for Sun Pharma's abbreviated new drug application for generic Acular ophthalmic solution on the first day following patent expiration. This strength of ketorolac is therapeutically equivalent to Acular ophthalmic solution, 0.5%, from Allergan. According to Caraco, ketorolac tromethamine ophthalmic solution is indicated for temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.  

U.S. physicians are torn over what the government should do to make health care more available and affordable, but they're surprisingly like-minded about one perceived scourge _ the insurance industry. As the U.S. Senate considers the health care bill that narrowly passed the House over the weekend, polls and pundits have tried to gauge doctors' support for change. The most up-to-date national survey of physicians, published in September in the New England Journal of Medicine, found that most favored expanding health coverage to the uninsured through a government-sponsored program _ the so-called public option. The House bill included this choice for needy individuals and small businesses, but it faces tough opposition in the Senate. Another survey, published last month in the same journal, found 70 percent of Massachusetts doctors support that state's three-year-old reform law, which increased public options, and created a government-regulated health insurance exch...

Ironwood Pharmaceuticals, a US-based pharmaceutical company, and Astellas Pharma, a Japanese pharmaceutical company, have entered into an agreement providing Astellas exclusive rights to develop and commercialize the investigational compound linaclotide in Japan, Indonesia, Korea, the Philippines, Taiwan, and Thailand. Under the terms of the agreement, Astellas would pay Ironwood $75 million in upfront and pre-commercial milestones, including a $30 million licensing fee, as well as escalating royalties on linaclotide sales. Astellas will lead clinical development in Japan and be responsible for all activities and expenses relating to clinical development, regulatory approval, and commercialization in the above mentioned territory. Linaclotide is currently in Phase III clinical development in the US for the treatment of irritable bowel syndrome with constipation and chronic constipation.  

Dr Reddy's Laboratories has submitted a marketing application for the generic version of US-based pharmaceutical company Pfizer's cholesterol-lowering drug Lipitor in the US. Pfizer said that in October 2009, Dr Reddy's Laboratories and Dr Reddy's Laboratories, Inc had notified the company that they had filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Lipitor. Under a settlement agreement with Pfizer, Ranbaxy has agreed to launch its generic by November 30, 2011. While the basic patent of Lipitor expires in the US in 2010, the related sub-patent expires in 2011.  

Concert Pharmaceuticals has initiated a Phase Ib clinical study with CTP-518, its investigational oral HIV protease inhibitor for the treatment of HIV infection. In connection with the start of this multiple ascending dose arm of the Phase I study, Concert will receive a $12 million milestone payment under the company's strategic alliance with GlaxoSmithKline (GSK). The Phase Ib study will be used to assess the ability of CTP-518 to maintain acceptable therapeutic blood concentrations without a boosting agent such as ritonavir. It will also be used to determine doses for subsequent studies in HIV-infected patients. The initial Phase I clinical trial is designed to evaluate the safety, tolerability and pharmacokinetics of CTP-518 in healthy volunteers after single and multiple doses. In addition, the Phase I study is intended to establish the pharmacokinetic enhancing effect of deuterium incorporation in CTP-518, and to determine whether CTP-518 dosed once-daily can maintain...

Enzon Pharmaceuticals, Inc has entered into a definitive agreement to sell its specialty pharmaceutical business to the Sigma-Tau Group for US$ 300 million plus an additional amount of up to US$ 27 million based on success milestones. Enzon will also receive royalties of 5 to 10 per cent on incremental net sales above a 2009 baseline amount from Enzon’s four marketed specialty pharmaceutical products through 2014. Enzon’s specialty pharmaceutical business includes four marketed products: Oncaspar, Adagen, DepoCyt, and Abelcet, as well as the manufacturing facility in Indianapolis, Indiana which will be purchased by a US subsidiary of Sigma-Tau Pharmaceuticals, Inc (Maryland). Sigma-Tau Pharmaceuticals will distribute the products in the US market. After the sale of these assets, Enzon’s businesses will consist of its royalties, Peg SN38 and our LNA and PEG technology platforms. “Enzon’s Board of Directors is evaluating options to return most of the va...

Cipla, the leading pharmaceutical company in India, has launched oseltamivir under the brand name of Antiflu. The only flu medicine from India to be prequalified by WHO, Antiflu would be sold under Schedule X category in India, like Virenza. These two Cipla drugs currently are the only to be widely recommended by various world health bodies. The launch comes in wake of WHO declaring flu as 'pandemic', which is anticipated to strike with the seasonal peak of winter. Unlike paracetamol prescribed to control fever, Antiflu and Virenza directly targets the virus and blocks its replication. Best results are seen if the medicines are taken within 48 hours of symptoms. Clinical trials suggest that theses drugs can reduce suffering considerably by over 24 hours. Timely usage of the drugs can reduce health complications, requirement for antibiotics and in the elderly even chances of getting a stroke.  

Lupin Ltd, a Rs 3,775 crore fifth largest Indian pharma major, has issued a Paragraph IV certification notice to Depomed, Inc regarding filing of an ANDA with the US FDA for a generic version of Glumetza (metformin hydrochloride extended release tablets), 500 mg and 1000 mg strengths.   Lupin’s certification notice alleges that Depomed’s US Patents (Nos. 6,340,475; 6,488,962; 6,635,280; and 6,723,340) listed in the FDA Orange Book for Glumetza are invalid and/or will not be infringed by Lupin’s commercial manufacture, use or sale of the products described in Lupin’s ANDA.

If rising costs and demanding regulators aren't enough to torment pharmaceutical executives, here's one more thing to worry about: Some of your employees might be wearing a wire. And collecting documents and voice mails. And looking for a lawyer who can help them blow the whistle on what they consider your dirtiest secrets. This year, the pharmaceutical industry is caught in a wave of whistle-blower cases, as employees help the government shine a bright light on what they consider fraudulent behavior. Pharmaceutical fraud accounts for the largest amounts of money paid out under the False Claims Act, a 146-year-old federal law that allows ordinary people, usually employees, to file civil actions against federal contractors for fraud, kickbacks and shoddy services. In January, Eli Lilly and Co. agreed to pay $1.4 billion to settle charges it illegally promoted its antipsychotic drug, Zyprexa, for unapproved uses. Nine whistle-blowers, former Lilly employees, split about...

Pfizer Inc. is wooing up-and-coming Israeli biotech Protalix Biotherapeutics for a possible buyout or partnership, the financial newspaper TheMarker reported Monday. Protalix shares, which have quintupled in price already this year thanks to the company's development of a promising new Gaucher's disease therapy, rose another 7 percent in early trading Monday. Protalix previously had been linked to reports of a possible acquisition by Teva Pharmaceutical Industries Ltd. Protalix and Teva have deep connections, with Teva chairman Eli Hurvitz serving as chairman of Protalix and Teva vice chairman Phillip Frost owning nearly 10 percent of Protalix, according to the Israeli business site Globes Online. And Protalix is looking for a deal. Chief Executive David Aviezer has said he expects a partnership to be lined up by the end of the year, according to TheMarker. The Israeli newspaper said Protalix's Uplyso drug to treat Gaucher's disease -- a buildup of fatty subst...

Sartorius, a bio-process, lab equipment and weighing scales major has invested Rs 45 crore (Euros 5 million) to set up a full-fledged facility including a R&D and production plant at Neelamangala the outskirts of Bangalore. It is equipped with an advanced research lab, manufacture, clean room and training centre.  

Millipore now offers the RFID technology with an European Union patent to the bio-pharma sector where gamma radiation is required. The company received the patent titled, 'Use of gamma hardened RFID tags in pharmaceutical devices'. The patent covers systems and methods for using RFID tags in biopharmaceutical environments where gamma radiation is used for sterilization. The memory device within the tag utilizes a technology that is not affected by gamma radiation. RFID tags may be applied to various components during manufacturing or immediately after final assembly and can be subjected to a gamma sterilization without risk of data loss or corruption. The company refers to RFID as 'Smart' technology.

Sosei Group Corporation, the biopharmaceutical company, announced that Sosei Co, Ltd, its wholly-owned Japanese subsidiary, has entered into a definitive distribution agreement with ASKA Pharmaceuticals Co., Ltd for the commercialisation of the emergency contraceptive pill SOH-075 (NorLevo). NorLevo is an oral emergency contraceptive 'morning after pill' which is used to prevent unwanted pregnancy after unprotected intercourse. NorLevo contains only levonorgestrel as an active ingredient. The dosing is started within 72 hours after unprotected sexual intercourse. NorLevo was first launched in Europe in 1999 and is currently approved in some 60 countries, the product being both safe and effective as an oral emergency contraceptive for post-coital use.

In one of the rarest distinctions ever witnessed at the Guinness World Records for Medicine, Indian gynaecologist and laparoscopic surgeon Dr Rakesh Sinha created history with a second time world record by excising a multiple fibroid uterus weighing a mighty 4.1 kg through laparoscopic hysterectomy at the Mumbai’s Beams Hospital last month. Dr Sinha broke the earlier record of two US-based doctors for laparoscopically removing a uterus weighing 3.2 kg. Dr Sinha’s first Guinness World Record came by in the year 2005 for removing the largest fibroid weighing 3.4 kg laparoscopically.

Novartis announced a USD 1 billion investment over the next five years, increasing R&D activities in China and confirming Novartis' long term commitment to China's further economic development, health reform and improving the health care of the Chinese people. The Novartis investment will include a significant expansion of The Novartis Institute of BioMedical Research (CNIBR) in Shanghai.

GE Global Research, the technology development arm of General Electric Company, has been awarded a two-year, US$ 1.2 million project. This is a grant under the federal stimulus programme from the National Institute of Biomedical Imaging and Bioengineering, part of the National Institutes of Health (NIH) and will be used to develop a low-cost transducer for portable ultrasound systems. The transducer is the device placed on the abdomen of an expectant mother which transmits and receives signals that generate real-time images of activity inside the womb.

Valeant Pharmaceuticals International announced that it has agreed to acquire the rights to several prescription and cosmetic dermatology products from a privately-held, Polish specialty pharmaceutical company. The products have approximately $8 million in annual sales and Valeant will acquire the rights to all products for approximately $18 million. A portion of the purchase price was paid upon signing and the remaining balance will be paid upon closing. The transaction is expected to close in the first quarter of 2010 and will be accretive to Valeant in 2010.

Marking the first international World Pneumonia Day on November 2, the GAVI Alliance plans to immunise 130 million children in poor countries against pneumonia, the world’s leading child killer. Pneumonia, a severe inflammation of the lungs usually caused by infection, is responsible for one in four child deaths, more than HIV/AIDs, malaria and measles combined. Each year, it kills approximately 1.8 million children under five years of age, making it the leading child killer. Despite its overwhelming toll, little attention and funding are given to it.