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Replies to #58520 on Biotech Values
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DewDiligence

06/11/08 4:25 AM

#63378 RE: DewDiligence #58520

Japanese Pharma Continue Buying Binge

http://www.reuters.com/article/marketsNews/idINT34755720080611

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Daiichi Sankyo to pay up to $4.6B for control of Ranbaxy

Wed Jun 11, 2008 3:10am EDT
By Edwina Gibbs

TOKYO (Reuters) - Japanese drug maker Daiichi Sankyo Co Ltd (4568.T) plans to take majority control of India's biggest drug maker Ranbaxy Laboratories Ltd (RANB.BO) in a friendly deal worth up to $4.6 billion.

The move represents a major foray into the field of generic drugs by Daiichi Sankyo and would be the latest in a string of large overseas acquisitions by Japanese drug makers.

Shares in Daiichi Sankyo, best known for its high blood pressure medication Benicar and the experimental blood thinner prasugrel, ended nearly 5 percent higher on early reports of a deal while Ranbaxy's shares were up 4 percent in afternoon trade.

The deal values Ranbaxy, one of India's biggest firms, at 737 rupees per share and represents a 31.4 percent premium to Tuesday's closing share price.

Under the deal, Daiichi Sankyo will buy the entire 34.8 percent controlling stake of Ranbaxy's founders, the Singh family, and also launch a bid to buy shares from the market.

The total transaction value is expected to be worth between $3.4 billion to $4.6 billion, the companies said in a statement.

"There's a global move to generics and Japan's a bit behind on this," Mitsushige Akino, chief fund manager at Ichiyoshi Investment Management, said after reports of the deal.

"India is a large market but even more important is the fact that Ranbaxy operates in a number of other countries. That's the real merit," he said.

Malvinder Singh, chief executive of Ranbaxy, plans to meet the media from 1.30 p.m. in India. (3:30 a.m. EDT)

The deal follows Takeda Pharmaceutical Co Ltd's acquisition of U.S. biotech firm Millennium Pharmaceuticals for more than $8 billion and Eisai Co Ltd's purchase of MGI Pharma Inc for $3.9 billion. Both Millennium and MGI Pharma are strong in cancer medicines.
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Preciouslife1

08/24/08 9:41 PM

#65565 RE: DewDiligence #58520

FDA Approves ALOXI(R) (Palonosetron HCl) Capsules For Prevention Of Acute Chemotherapy Induced Nausea And Vomiting

Article Date: 24 Aug 2008 - 1:00 PDT
http://www.medicalnewstoday.com/articles/119130.php

Eisai Corporation of North America and its partner Helsinn Healthcare SA announced that the U.S. Food and Drug Administration (FDA) has approved a new oral formulation of ALOXI(R) (palonosetron hydrochloride) for the prevention of chemotherapy-induced nausea and vomiting (CINV).
ALOXI Capsules 0.5 mg for oral administration is indicated for the prevention of acute nausea and vomiting following initial and repeat courses of moderately emetogenic chemotherapy. A single 0.5 mg ALOXI Capsule is administered approximately one hour prior to the start of chemotherapy.


ALOXI (palonosetron hydrochloride) injection 0.25 mg, a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist, has been available in the United States for intravenous administration since 2003 for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.
A single 0.25 mg intravenous dose of ALOXI is administered approximately 30 minutes before the start of chemotherapy.

About Chemotherapy-Induced Nausea and Vomiting (CINV)

Research has shown that patients with cancer consider CINV among the most dreaded side effects following therapy. Despite prophylactic antiemetics, on the day of chemotherapy, about 30-45 percent of patients experience nausea or vomiting or require rescue therapy following administration of moderately emetogenic chemotherapy. Failure to control acute nausea and vomiting on the first day of chemotherapy will increase the risk of nausea and vomiting on subsequent days and in subsequent cycles of chemotherapy.

About ALOXI Capsules for Oral Administration

ALOXI (palonosetron HCl) Capsules 0.5 mg for oral administration is indicated for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy. One ALOXI 0.5 mg capsule is administered approximately one hour prior to the start of chemotherapy.

ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components.
There were no adverse reactions that occurred greater than or equal to 5 percent for the 0.5 mg oral dose. The most commonly reported adverse reactions were headache (3.7 percent) and constipation (0.6 percent).

Please see the ALOXI prescribing information, available at http://www.ALOXI.com, for important additional details.

About ALOXI Injection

ALOXI (palonosetron HCl) injection 0.25 mg is the first and only 5-hydroxytryptamine-3 (5-HT3) receptor antagonist to be indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy. ALOXI injection 0.075 mg is also approved as a single intravenous dose administered immediately before the induction of anesthesia for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.

ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components.
The most commonly reported adverse reactions (incidence greater than or equal to 2 percent) in ALOXI CINV trials were headache (9 percent) and constipation (5 percent), and in PONV trials, the most commonly reported adverse reactions were QT prolongation (5 percent), bradycardia (4 percent), headache (3 percent), and constipation (2 percent).

Please see the ALOXI prescribing information, available at http://www.ALOXI.com, for important additional details.

Eisai licensed the North American distribution and marketing rights for ALOXI from Helsinn Healthcare SA.

About HELSINN HEALTHCARE SA

HELSINN HEALTHCARE SA is a privately owned pharmaceutical group with headquarters in Switzerland and is the worldwide licensor of palonosetron. HELSINN's core business is the licensing of pharmaceuticals in therapeutic niche areas. The company's business strategy is to in-license early stage new chemical entities and complete their development from the performance of pre-clinical/clinical studies and CMC development to the attainment of market approvals in strategic markets (U.S. and Europe). HELSINN's products are eventually out-licensed to its marketing partners for distribution. The active pharmaceutical ingredients and the finished dosage forms are manufactured at HELSINN's cGMP facilities and supplied worldwide to its customers. For more information about HELSINN, please visit the company's Web site at http://www.helsinn.com.

About Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care.

Eisai Corporation of North America supports the activities of its operating companies in North America, which include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery.

Eisai Corporation of North America
http://www.eisai.com