Templeton Backs Sun Pharmaceutical Bid for Taro

Mark Mobius, chairman of Templeton Asset Management Ltd., backed Sun Pharmaceuticals Ltd.’s year- long bid to buy Israeli drugmaker Taro Pharmaceutical Industries Ltd., saying he wants the deal completed “as fast as possible.”

Taro sued the Indian drugmaker for failing to disclose key information in its offer. Buying Taro would help Mumbai-based Sun expand its market reach in the U.S., where demand for generics will grow as health-care costs surge and more blockbuster drugs lose patent protection.
Templeton owns 10 percent of Taro, located 30 kilometers (19 miles) from Tel Aviv. Mobius said he wants Sun to take over the Israeli company to improve disclosure of Taro’s accounts.

“There have been no audited accounts from the Taro management and they recently wanted to have a shareholders’ meeting to approve dispensation of the directors for responsibility for the accounts,” Mobius said in a Bloomberg Television interview. “That’s alarming so we said we wanted to back Sun to take over this company as fast as possible so that we could see those accounts.”

Roanne Kulakoff, a spokeswoman for Taro, couldn’t immediately be contacted in New York, where her voice mail said she is out of the office until Dec. 3.
Sun, India’s largest drugmaker by market value, fell 0.4 percent to 1,533 rupees as of 11:56 a.m. after surging as much as 6.4 percent.

“Although the news that the third-largest shareholder is now backing Sun’s bid to take control of Taro is positive, it has no implications for the outstanding legal dispute,” Abhishek Singhal, an analyst at Macquarie Group, wrote in a note to clients today. “A positive court ruling is essential for Sun to take eventual control.”

Source: Bloomberg.com

Pharmacists happy over bigger POYC

The Malta Chamber of Pharmacists and the Pharmaceutical Division of the GRTU, Chamber of Small and Medium Enterprises, expressed satisfaction that the Minister of Finance had in the Budget speech consolidated the government's commitment to the further roll-out of the Pharmacy of Your Choice scheme, to serve 50,000 new patients in the near future.

This statement is a further seal of success that endorses the tripartite vision for primary health care through the provision of personalised pharmaceutical care services by community pharmacists to benefit registered patients, the chamber said.

“This is a further step towards the full attainment of the objective where Malta should rank positively with the other EU member states in equitable access to community pharmacists’ services to patients including the medicines they need.”

Source: The Independent

Addex set for partner deal after drug hits target

Swiss biotech group Addex Pharmaceuticals' said its lead drug candidate met its main target in a mid-stage clinical trial in heartburn, potentially paving the way for a lucrative partnering deal.
Analysts say positive data on ADX10059 sets the stage for a deal with a bigger drugmaker, which would provide much-needed funds for Addex, a start-up company that does not yet have a product on the market.

"With good phase IIb data Addex's next step is to license the drug to a larger pharmaceutical company. We reckon this process has already started, thus would expect a deal in 2010," said Andrew Weiss, analyst at Swiss bank Vontobel.
Addex shares had jumped 16 percent to 37 Swiss francs by 0821 GMT on Monday, compared with an almost flat European healthcare sector .SXDP.

In a Phase IIb trial, the drug increased the number of symptom-free days fivefold when used as a monotherapy in gastroesophageal reflux disease (GERD), which causes heartburn, the company said on Monday.

Drug discovery groups like Addex are aiming to match the success of Actelion (ATLN.VX), which has developed its own billion dollar selling drug, but many have fallen by the wayside as medicines fail to live up to potential and cash runs short.

The problems of such small start-up biotechs are shown by Addex's stock, which had lost 16 percent this year before Monday, underperforming a stronger European sector.

Source: reuters.com

Simcere Pharma Q3 Profit Plunges On Higher Expenses - Update

Chinese drug manufacturer Simcere Pharmaceutical Group (SCR: News ) Monday reported a 82% decline in net income for the third quarter, impacted negatively by higher expenses.
Net income for the quarter attributable to the company was RMB 16.43 million or RMB 0.14 per share, much lower than RMB 91.16 million or RMB 0.72 per share in the prior-year quarter. In US dollars, net income attributable to Simcere was $2.41 million or $0.02 per share for the most recent quarter.

Earnings per American depository shares, or ADS, plunged to RMB 0.29, or US$0.04, from RMB 1.44 in the year-ago quarter.
On an average, four analysts polled by Thomson Reuters expected earnings of US$0.09 per share for the quarter. Analysts' estimates typically exclude special items.
Total third-quarter revenues increased slightly to RMB 443.7 million or US$65.0 million from RMB 443.4 million a year earlier. Analysts estimated revenues of US$69.09 million for the quarter.

Commenting on the results, Jinsheng Ren, chairman and chief executive officer, said, "Our sales and gross profit margins remained stable this quarter. However, lower sales in Endu, impacted by the restructuring of the sales team, and an increase in sales and marketing expenses for new to market drugs like Anxin and Sinofuan, caused a significant decrease in operating income."
Product revenues slipped to RMB 439.02 million from RMB 441.21 million in the prior-year quarter. Within this, revenues from Endu, Simcere's patented anti-cancer biotech product, amounted to RMB 21.6 million, or US$3.2 million, down 60.2% from RMB 54.4 million for the same period in 2008.

Source: rttnews.com

Swine flu causes surge of garlic sales in Serbia

Belgrade's open-air markets were a welter of busy customers on Friday, pushing and shoving to buy one item — garlic.
In Serbia, garlic has long been regarded as a good-luck charm and a guard against many ailments. As far as the public is concerned, that includes the swine flu pandemic, which recently has spread in Serbia and triggered near panic among the local population.
That is now evident in Belgrade's produce markets, where the price of garlic has shot up, thanks to a sudden increase in demand. The smell of the little white cloves also has become prevalent in public places as people munch on them as if eating apples.

Health officials have publicly urged the population not to take garlic's healing properties so seriously. Instead, they recommend opting for more conventional precautions, such as washing hands, wearing face masks, or eventually getting vaccinated.
But those calls seem to have been in vain.

"Garlic is the best, forget the vaccines," said Marko Jankovic, an elderly Belgrader, with the pungent smell of garlic obvious as he spoke at the crowded Kaleniceva Pijaca market. "From the vaccine, you can get sick. From garlic, you can only get bad breath."
Facing a surge of swine flu cases, Serbia's Health Ministry on Friday ordered 3 million vaccines from Swiss pharmaceutical company Novartis AG.

The authorities said Serbia has about 270 proven swine flu cases and eight deaths — up from about 130 cases and two deaths at the beginning of November.
In many parts of the world, the distinct taste and smell of garlic are considered essential in many meals. But in Serbia — as elsewhere in the Balkans — many people consider it more important than that.

Garlic is kept on doorsteps or in pockets to keep vampires away, and under babies' pillows to ensure a healthy and prosperous life. Serbs often consume garlic as a snack together with slivovitz, a strong plum brandy.
These days, Serbian media often compare what happened at two popular music festivals as proof of the alleged medicinal virtues of garlic.
That's because Serbia's first swine flu cases were confirmed after the annual Exit rock music festival in July in the town of Novi Sad, where authorities say the mostly young audience indulged in beer and marijuana.

By contrast, the media say, no swine flu cases resulted from the equally popular folk music festival in Guca, central Serbia, where the generally older, more tradition audience gorged on meat dishes heavily spiced with garlic, and drank slivovitz.

For centuries, garlic has been regarded by many people around the world as a successful medical treatment for everything from indigestion to respiratory problems. Recent medical studies also have shown that garlic can reduce a person's blood pressure.

But in Serbia, doctors are telling the public to stop considering it as a swine flu defense.
"People must take this pandemic more seriously and focus on real prevention and medicine," not garlic, said Zoran Djordjevic, a virology doctor at a Belgrade hospital.

Source: rep-am.com

Themis Medicare drops

Themis Medicare declined 2.06% to Rs 145.05 at 13:38 IST on BSE, after a fire and explosion took place in one of the sections of the company's Vapi factory on Friday, 13 November 2009.
The company made this announcement during trading hours today, 16 November 2009.
Meanwhile, the BSE Sensex was up 207.51 points, or 1.23%, to 17,056.34.
On BSE, 1,469 shares were traded in the counter as against an average daily volume of 3,948 shares in the past one quarter.

The stock hit a high of Rs 149 and a low of Rs 149 so far during the day. The stock had hit a 52-week high of Rs 164.80 on 5 November 2009 and a 52-week low of Rs 49 on 6 March 2009.
The small-cap stock had outperformed the market over the past one month till 13 November 2009, rising 21% as compared to the Sensex's 1.04% fall. It had also outperformed the market in the past one quarter, gaining 44.07% as compared to the Sensex's return of 8.57%.
The company's equity capital is Rs 8.05 crore. Face value per share is Rs 10.
The current price of Rs 145.05 discounts the company's Q2 September 2009 annualized EPS of Rs 47.20 by a PE multiple of 3.07.

The company is fully insured and steps are being taken to restore normalcy at the exploded section of the plant. The other plants are in operation, the company said.
Themis Medicare's net profit galloped 787.9% 9.50 crore on 10.9% rise in net sales to Rs 60.98 crore in Q2 September 2009 over Q2 September 2008.

The company is engaged in manufacturing and selling pharmaceutical products. The group's products are used in therapeutic areas like antituberculosis, antimalarials, cardiology, pain management, anti-infectives, haematinics, Health and Nutrition. It also engaged in co-marketing its research-based formulations with other pharmaceutical companies in India and abroad.

Source: indiainfoline.com

Bristol-Myers to spin off Mead Johnson Nutrition

Drug-manufacturer Bristol-Myers Squibb Co. announced on Sunday that it would spin off its Mead Johnson Nutrition Co. in order to focus on its bio-pharmaceutical business.
Under the deal, Bristol-Myers will give its shareholders roughly $1.11 of Mead Johnson shares for each $1 in Bristol share they tender.

The accurate ratio will be determined by a 10 per cent discount to the daily volume-weighted average prices of Bristol-Myers and Mead Johnson shares from December 8 to December 10.
New York-based Bristol-Myers, which possesses 83 per cent of Mead stock, said that the deal was a part of its divestment strategy that would transform it from a traditional drug firm into a bio- pharmaceutical company.

James M. Cornelius, Chief executive of Bristol-Myers said, "With a successful execution of this split-off, we fully consider ourselves a BioPharma company."
The exchange offer is scheduled to expire on December 14.

Source: topnews.co.uk

Glenmark settles patent dispute with Medicis

Pharma firm Glenmark today said it has settled all pending patent disputes with US-based Medicis Pharmaceutical Corp over a skin disease drug, besides signing a licensing agreement for new drug delivery system (NDDS).

The company through its US-based subsidiary Glenmark Generics Inc has announced the settlement of all litigation pending between Medicis and Glenmark related to the generic version of Vanos and Loprox gel, used in the treatment in dermatology therapeutic area, Glenmark Pharmaceutical spokesperson told PTI.

Under the terms of the agreement Glenmark will be able to market and distribute the generic version of Vanos cream under license from Medicis from December 2013. In addition, Glenmark will be able to launch the generic version of Loprox gel in 0.77 per cent strength immediately, he added.

Source: ptinews.com

Top Five International Pharmaceutical Company Awards Comprehensive Cardiac Safety Study to iCardiac

iCardiac Technologies, Inc., a global leader in advanced cardiac core lab services and QT analysis, announced today that a top five pharmaceutical company has awarded iCardiac a comprehensive "Thorough QT" (TQT) study. iCardiac will provide end-to-end study management, international equipment deployment and scientific reporting, as well as advanced ECG analytics. The study will utilize iCardiac's Highly Automated QT and Dynamic QT beat-to-beat(sm) service offerings to dramatically improve study precision and reduce false positives and negatives.

"iCardiac's ability to reduce sample size as well as false positives in TQT studies continues to be well received by the pharmaceutical industry," said Sasha Latypova, Executive Vice President. "As these methods are now accepted as part of the regulatory review of cardiac safety, we expect the speed of adoption to continue to accelerate."

In October 2005, the FDA introduced a new guidance for industry (ICH E14) requiring the evaluation of pro-arrhythmic potential of new drugs by measuring the QT segment of ECGs collected in clinical trials. The dissatisfaction among pharmaceutical developers with the poor precision, high rate of false positives/negatives and high cost of the "gold standard" manual or semi-automated QT measurements has lead to efforts toward providing more advanced cardiac safety analytics.

Source: EARTH TIMES

Sanofi Taps Biotech Firm to Bolster Its Pipeline

Increasing its bet on biotechnology, Sanofi-Aventis said it would pay an additional $1 billion over eight years to Regeneron Pharmaceuticals for the discovery of new drugs.

The agreement, announced Tuesday, is an extension of one signed in 2007, The New York Times’s Andrew Pollack reported. Sanofi, a big drug company based in France, had previously agreed to provide $100 million a year to Regeneron, a biotechnology company based in Tarrytown, N.Y. The amount is being increased to $160 million a year, and the pact is being extended five additional years through 2017.

Dr. Leonard S. Schleifer, the chief executive of Regeneron, said the arrangement represented a way for a large pharmaceutical company and a biotechnology company to collaborate without suffocating the smaller company.

“They leave Regeneron and its culture to do its thing,” he said. “It’s everything a biotech company could dream of.”
Sanofi already owns 19 percent of Regeneron as a result of previous deals but will not increase its stake as part of the new transaction.

The drugs being developed are monoclonal antibodies, which are engineered versions of proteins naturally made by the immune system. Regeneron has developed genetically engineered mice that can produce human antibodies.

Under the deal, if Regeneron develops a drug it believes is ready for clinical trials, Sanofi can opt to co-develop it with Regeneron. So far, four antibodies have entered clinical trials in two years, and the companies aim to put four or five new ones into trials each year. That rate is higher than the norm for the industry.

Like most big pharmaceutical companies, Sanofi-Aventis is negotiating deals with smaller companies to bolster its pipeline. In particular, it and other big companies are trying to move more into biotechnology, making drugs from living cells instead of from the chemicals they usually use.

In some cases, the biotech drugs can do things that chemical drugs cannot. The biotech drugs are also not subject to the same sudden generic competition that can devastate sales of chemical drugs. Sanofi recently started facing generic competition in some markets for its big-selling anti-clotting drug Plavix and its cancer drug Eloxatin.

Source: NEW YORK TIMES

Vertex Pharmaceuticals Announces Agreements to Exchange $109.0 Million of its 2013 Convertible Senior Subordinated Notes into Common Stock

Vertex Pharmaceuticals Incorporated announced today that holders of its 4.75% Convertible Senior Subordinated Notes due 2013 have agreed to exchange approximately $109.0 million in aggregate principal amount of those notes and accrued interest for approximately 4.8 million shares of the Company’s common stock, which is approximately 140,000 shares more than the number of shares into which the notes were convertible under their original terms.

The Company anticipates that the exchanges will be completed by the close of business on November 13, 2009. Upon completion of the exchanges, the aggregate principal amount of the Company’s 4.75% Convertible Senior Subordinated Notes due 2013 will be reduced to approximately $35.0 million. Upon issuance of the common stock in exchange for the notes, Vertex will have approximately 186 million shares of common stock outstanding.

This announcement is neither an offer to exchange nor a solicitation of an offer to exchange any of these securities. The exchanges are exempt from registration under Section 3(a)(9) of the Securities Act of 1933.

Source: Newsticker.welt.de

China Aoxing Pharmaceutical Company to Present at Brean Murray, Carret & Co. 2009 China Growth Conference

China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China Aoxing"), a China-based pharmaceutical company specializing in research, development, manufacturing and distribution of narcotic and pain-management products, today announced that the Company will present at the 2009 China Growth Conference held by Brean Murray, Carret & Co. at the The Millennium Broadway Hotel in New York City, on November 19, 2009.

The Company will update the Company business including product portfolio, development pipeline, financial highlights and its long-term growth strategies.
For further details, please contact your institutional sales representative.

Source: CNN.Money.Com

Pharmaceutical company GlaxoSmithKline to donate 50 million doses of swine flu vaccine to WHO

Pharmaceutical company GlaxoSmithKline will donate 50 million doses of H1N1 vaccine to the World Health Organization (WHO). APA reports that the related agreement was signed in Geneva.

WHO Director-General Margaret Chan said WHO will work to see that these vaccines are distributed to those who need them.

GlaxoSmithKline expects to prepare the first shipments of vaccine to the WHO by the end of November. WHO has prepared a list of 95 developing countries that are slated for receiving vaccines from GSM, and it intends to cover 10 percent of the population in these countries.

Source: APA.Az

Jazz Pharmaceuticals to Present at Investor Conference

Jazz Pharmaceuticals announced today that company management will present a corporate overview at an upcoming investor conference.

Robert M. Myers, President of Jazz Pharmaceuticals, will speak at the Lazard Capital Markets 6th Annual Healthcare Conference on Wednesday, November 18, 2009 at 2:15 p.m. EST at The St. Regis Hotel in New York City.

After the presentation, the slides may be accessed by visiting the Investors section of the Jazz Pharmaceuticals website. The slides will be available on the site for two weeks following the presentation.

Source: Money.CNN.Com

Pharma bracing for tougher FDA guidance on trials

Pharmaceutical companies in New Jersey and elsewhere face more stringent requirements from the Food and Drug Administration on disclosures of mishaps in clinical trials.And while industry groups and advisers have broadly welcomed the increased transparency and the move toward safer drugs, they want these actions to strike a balance with the costs of complying with them.

As of Sept. 27, the FDA requires drug manufacturers to include the general public in disclosures on “adverse” and “serious adverse” events beyond the regulator and patients participating in trials, said Satish Tadikonda, president of Virtify Inc., in Cambridge, Mass., which provides compliance services to life sciences companies.

Adverse events are side effects like rashes or headaches, while serious adverse events are those that result in death, disability or life-threatening situations, among others, Tadikonda said.

“The playing field is leveled across the world,” Tadikonda said. “Previously, if you wanted to get competitive intelligence on a drug, you had to read numerous trade journals, and patients had to guess whether they could participate in a trial.” Now, the disclosures have to be posted at www.clinicaltrials.gov, a registry developed by the National Institutes of Health and the FDA.

Tadikonda said the regulator’s actions follow high-profile lawsuits, such as those involvingMerck’s painkiller drug Vioxx and GlaxoSmithKline’s diabetes drug Avandia. He said his firm has worked with several New Jersey-based pharmaceutical companies, the FDA and the NIH to clarify and interpret the new rules.

The industry’s pre-eminent advocacy group, the Washington, D.C.-basedPharmaceutical Research and Manufacturers of America, supports FDA’s move, and in October issued its own set of principles to achieve the goals set forth by the agency, according to Jeffrey K. Francer, its assistant general counsel.

But the new disclosure requirements would “necessarily increase the amount of expense in the drug-development process,” Francer said. “It is already enormously expensive, and it is important to make sure that the benefit of additional requirements outweighs the costs.”

Francer said striking a balance between regulatory requirements and compliance costs will be especially important as NIH defines the rules to post the results of clinical trials on the Web.

“The NIH should do so in a way that protects the confidential commercial information and trade secrets [of drug companies] and does not jeopardize companies that register [clinical trials] in the U.S.,” Francer said.

NIH could use specific steps to lower costs, for instance, an automated reporting process that would accept PDF submissions, Francer said. PhRMA has also advocated the International Conference on Harmonization’s format for summarizing clinical trails information, which is accepted by European and Japanese regulators.

Source: NJBiz

Valeant Pharmaceuticals Reports Third Quarter Financial Results

Valeant Pharmaceuticals International VRX today announced third quarter financial results for 2009.

“Valeant continues to perform well, generating strong earnings growth in the third quarter,” stated J. Michael Pearson, chairman and chief executive officer. “All of our businesses are growing and generating positive cash flows this quarter. In particular, I would like to note our 18% organic growth rate from total product sales, at constant currency, and our $65 million of adjusted cashflow from operations.”

Revenues:

Total revenue was $220.3 million in the third quarter of 2009 as compared to $168.4 million in the third quarter of 2008, an increase of 31%.

Product sales in the Specialty Pharmaceuticals segment were $101.6 million in the third quarter of 2009, as compared to $70.1 million in the third quarter of 2008, an increase of 45%. At constant exchange rates, Specialty Pharmaceuticals product sales increased 47%. Within the SpecialtyPharmaceuticals segment, alliance and service revenue was $25.6 million in the third quarter of 2009, which included an $8.5 million profit share related to the 1% clindamycin and 5% benzoyl peroxide product (IDP-111) that was launched by Mylan in August 2009, $5.0 million related to the Dow services business, and $3.8 million of revenue from the GlaxoSmithKline (GSK) collaboration. Because the company entered into the GSK collaboration agreement in October 2008 and acquired Dow in December 2008, no alliance or service revenue was recorded in the third quarter of 2008.

Product sales in Branded Generics - Latin America were $40.7 million in the third quarter of 2009 as compared to $42.6 million in the same period in 2008, a decrease of 5%. At constant exchange rates, product sales in Latin America in the third quarter of 2009 increased 19% as compared to the third quarter of 2008.

Product sales in Branded Generics - Europe were $40.2 million in the third quarter of 2009 as compared to $40.4 million in the same period in 2008, essentially flat. At constant exchange rates, product sales in Europe in the third quarter of 2009 increased 29% as compared to the third quarter of 2008.

Ribavirin royalties were $12.2 million in the third quarter of 2009 as compared to $15.2 million in the third quarter of 2008, a decrease of 20%. This expected decrease is entirely attributable to the expiration of royalty terms in certain European countries on the ten-year anniversary of product launches in the respective countries.

Source: MSN Money Central

Obesity treatment signed for 1 Billion to Takeda

Takeda Pharmaceutical Co and Amylin have signed a pact potentially worth over $1 billion to the US firm to develop and commercialise products for the treatment of obesity “and related indications”.

The deal covers pramlintide/metreleptin and davalintide, which are compounds currently in Phase II. Cashwise, Amylin will receive a one-time up-front payment of $75 million and is eligible to receive certain development, commercialisation and sales-based milestones that could exceed $1 billion. It also provides for future tiered, double-digit royalty payments.

Amylin will be responsible for development through Phase II at home and Takeda will do the same outside the USA. In most instances, Amylin will be responsible for 20% of development costs associated with obtaining approval for products in the USA and Takeda will pay the rest and 100% abroad.

Yasuchika Hasegawa, chief executive of the Japanese drugmaker, said that by leveraging his firm’s “global development and commercial infrastructure we look forward to maximising the significant potential of the products under this agreement”. He added that both have extensive experience in the diabetes and metabolic disease area, and this collaboration should allow us to more quickly bring promising new treatments to patients in need”.

His counterpart at Amylin, Daniel Bradbury, said his company “recognises the enormous potential of this collaboration to advance more options in obesity treatment more quickly than either company could do alone”.

Sales of Takeda’s key drugs fall

News of the deal came a day after Takeda reported net income for the six months ended September 30 of 189.63 billion yen (around $2.10 billion), a 164.2% increase over the like, year-earlier period when the company booked charges related to the acquisition of Millennium Pharmaceuticals. Sales fell 6.4% to 755.45 billion yen, mainly due to the strength of Japan’s currency.

Takeda’s biggest earner, the diabetes drug Actos (pioglitazone), brought in 194.80 billion yen, down 4.1%, while the gastrointestinal drug Prevacid/Takepron (lansoprazole) decreased 11.5% to 132.00 billion yen. Sales of the blood pressure drug Blopress (candesartan cilexetil) were down 5.8% to 112.40 billion yen, while turnover from the prostate cancer treatment Leuplin (leuprorelin) fell 9.0% to 59.20 billion yen.

Takeda maintained its full-year profit forecast of 280 billion yen but slightly lowered its sales target from 1.50 trillion yen to 1.48 trillion yen.

Source: Pharma Times

GlaxoSmithKline moves EAP provider

Pharmaceutical giant GlaxoSmithKline (GSK) has switched its employee assistance programme (EAP) providers to give staff greater access to cognitive behavioural therapy (CBT).

The firm has switched from Ceridian to PPC, and its 16,000 employees can now access face-to-face CBT counselling, as well as an online service, where they will be asked a series of questions about their problems.

Employees are then given information to help them understand their difficulties and access effective treatment. They can contact a telephone adviser for further assistance.

Harsha Modha, GSK’s director of benefits programmes for the UK, said the service would reduce the stigma around mental health issues in the workplace, and provide the right environment for staff to seek help.:

Source: Employee Benefits