Sun Pharmaceuticals

Sun extends Taro offer pending court ruling

Calisha Myers — Fri, 03 Oct 2008 15:38:17 -0400

Sun Pharmaceuticals's subsidiary, Alkaloida Chemical Company, has extended its tender offer for Taro Pharmaceuticals until November 7, 2008, according to a statement released today. The two companies were negotiating a merger when Taro called it off back in May. Apparently, Sun's $10.25 per share offer was not adequate. But Sun Pharma had no intentions of calling off the merger and commenced a tender offer at $7.75 per share in June.

The tender has been extended to comply with a continuance issued by Israel's Supreme Court while it decides the pending case, brought by Taro against Alkaloida, regarding the regulations of the special tender offer under Israel Law. That case is scheduled to begin on December 8, 2008.

The Tel-Aviv District Court previously ruled in favor Sun Pharma that a special tender offer based on Israel law was not required.

In August, the FTC ruled that the Sun-Taro merger would give the company a monopoly on generic anticonvulsant drugs in U.S. As a result, Sun consented to an order requiring the company to sell the drugs to India pharma Torrent should the merger be completed.

- check out the Sun Pharma release

Sun Pharmaceuticals receives favorable ruling

Christe Bruderlin-Nelson — Wed, 27 Aug 2008 09:39:13 -0400

A Tel-Aviv court ruled in favor of Sun Pharmaceuticals, which is headquartered in India, to purchase the ordinary shares of Taro, a United States company.

Taro, which was the plaintiff in the case, said that Sun should have made a special tender offer based on Israeli law, but the court ruled that was unnecessary and that Taro should have paid closer attention to the documents before signing. Therefore, Sun's Alkaloida Chemical Co. Exclusive Group Ltd. unit offer will stand.

The two companies first agreed that Alkaloida would purchase Taro via a merger agreement on May 18, but Taro terminated the agreement just 10 days later. Then, Alkaloida moved forward with an option to acquire Taro shares on June 25. The tender offer will now close on September 3.

- read the story in Forbes
- see more at Nasdaq
- find the Market Watch coverage

Sun aims to strongarm Taro shareholders

Tracy Staton — Thu, 26 Jun 2008 10:23:14 -0400

India's Sun Pharmaceuticals just won't take no for an answer. After its merger deal with Israel's Taro Pharmaceuticals fell apart last month, Sun now says it's going to try to force the company's controlling shareholders to sell out. "We will do everything required to preserve our rights," Sun's chairman said in a statement. Both companies are suing over the collapsed deal. Report

Sun keeps tabs on Taro facility sale

Christe Bruderlin-Nelson — Wed, 25 Jun 2008 12:07:07 -0400

Sun Pharmaceuticals wrote a second letter to Taro, citing major concerns about the sale of Taro's Irish facility. The letter specifically requests full disclosure of all facts related to the sale.

In the letter, written to Dr. Barrie Levitt, Chairman of the Board of Directors of Taro, Dilip Shanghvi, Chairman and Managing Director said, "Taro has been unable to address our substantive objections to the proposed sale of Taro's Irish subsidiary ("Taro Ireland"). Instead, you have tried to deflect attention from the logic of our reasoning by accusing us of breaching our duty of good faith to Taro and its other shareholders," adding, "We find this laughable."

The letter follows termination of a merger agreement between the two companies.

- read the letter at the Sun Herald
- get more from Trading Markets

Wyeth pounces on Sandoz's copycat Protonix

Tracy Staton — Wed, 21 May 2008 10:46:11 -0400

Wyeth is going toe-to-toe with Novartis. The Protonix maker--and its partner, Nycomed--filed suit against Novartis' generics arm, saying its copycat drug violates the heartburn med's U.S. patent. Sandoz, you'll recall, filed last month for FDA approval of an injectable form of the drug.

It's just the latest twist in the rapidly lengthening story of copycat Protonix. Last year, Teva Pharmaceuticals launched its version, but stopped shipping to sit down with Wyeth at the negotiating table. No settlement of the companies' patent fight has yet been reached, but in the meantime, Wyeth teamed up with Prasco Laboratories to sell an authorized generic. Soon after, a division of India's Sun Pharmaceuticals released its own version.

Wyeth's sales--both branded and generic--dropped by 66 percent during the first quarter--a painful loss, considering the fact that Protonix once was the drugmaker's biggest seller. It's still defending its Protonix patent, though, and plans to ask for lost profits and damages from both Teva and Sun when the patent case goes to trial.

- see the Wall Street Journal story

Caraco to withdraw misshaped metformin

Tue, 25 Mar 2008 07:59:54 -0400

A couple of weeks ago, the Los Angeles Times ran a big package about generic meds. Are they really as good as the brand-name versions? Well, the FDA can answer that question about one generic in particular today. The agency asked Caraco Pharmaceutical Laboratories, the U.S. subsidiary of Indian generics giant Sun Pharmaceuticals, to withdraw its diabetes med metformin hydrochloride, "citing efficacy and quality issues," the Business Standard reports.

Caraco will have to withdraw seven lots of the metformin because some tablets were too small and others too big, so like Goldilocks, patients might not have received the correct dose.

- read the Business Standard article
- check out the generics coverage at the LA Times

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ALSO NOTED: MedImmune acquisition could pay dividends; Sun challenges J&J patent;

Thu, 28 Feb 2008 06:59:50 -0500

> Analysts say AstraZeneca's buyout of MedImmune could pay extra dividends as health officials expand their recommendations for an flu jab to all children between the ages of six months and 18. Report

> Sun Pharmaceuticals is challenging Johnson & Johnson's patent on the schizophrenia med Risperdal in the Mumbai, India, patent office. Report

> Pfizer has launched its stop-smoking med in India under the name Champix. Report

> AstraZeneca says it will push ahead with late-stage studies of Recentin for colorectal cancer after shelving plans for a Phase III in non-small cell lung cancer due to toxicity concerns. Report

> The nation's top biotech analysts have looked over the field of presidential candidates and announced a big winner: stem cell companies. Report

> GSK's secret vaccine adjuvant is drawing attention. Report

> Maryland lawmakers are considering a bill that could pump between $5 million and $10 million next year into a program to support the development of nano-biotech companies. Report

> The CDC has greatly expanded the population of people it's recommending for an annual flu shot, saying everyone aged six months to 18 should get the an annual jab. Report

And Finally… An MIT student found a way to make antibiotics more effective, winning a $30,000 prize for his efforts. Report

Sun copycat to cut $500M off Wyeth sales

Thu, 20 Dec 2007 06:59:58 -0500

Wyeth shouldn't be facing generic competition for Effexor XR until 2010. It already fought that battle in court, prevailing over patent challenges in 2005. But Sun Pharmaceuticals figured out how to put the drug in pill, rather than capsule, form--and because the active ingredient goes off patent in June, Sun will likely be able to launch its copycat med. Analysts expected Sun's drug to shave off 10 to 15 percent of Effexor XR sales. That's a $500 million-plus hit to Wyeth's top line.

Meanwhile, Wyeth has other problems, too. Generics firms are taking aim at Protonix, its blockbuster heartburn drug. Bifeprunox, its experimental antipsychotic, got a "not approvable" letter from the FDA in August. The agency in July asked for another one-year study before it will approve Pristiq, an antidepressant Wyeth wants to market for menopausal symptom relief.

And now Wyeth must deal with Sun's Effexor-like pill. The Indian generics maker will have a tough job marketing the new drug, because it's not an exact copy and so can't be automatically substituted for Effexor XR; docs will have to write prescriptions specifically for the Sun product. But that sales challenge isn't likely to help Wyeth execs sleep better at night.

- read the AP report

ALSO: Take a look at Wyeth's pipeline. Report

Related Articles:
Wyeth gets OK to use Effexor XR for panic disorder. Report
Wyeth names Poussot CEO. Report
Wyeth stumbles badly trying to develop new drugs. Report
Wyeth stock down after several setbacks. Report

ALSO NOTED: Caraco gets FDA nod for GSK seizure drug; Mylan prices offering of stock;

Wed, 14 Nov 2007 06:59:50 -0500

> Caraco Pharmaceutical got tentative FDA approval for its copycat form of GlaxoSmithKline's Lamictal, a remedy for seizures and bipolar episodes that sold some $1.89 billion in the 12 months ended Sept. 30. Release

> Mylan announced that it has priced its new offering of preferred stock at $1,000 per share and common stock at $14 per share; the company intends to sell 1.86 million shares of the former and 53.5 million of the latter. Release

> Lundbeck reported a 37 percent boost in third-quarter profits to about $170 million, excluding the one-time payment from Takeda Pharmaceutical on the commencement of their co-development deal. Release

> Orion is suing Sun Pharmaceuticals to protect its patent on Stalevo, a treatment for Parkinson's Disease. Report

> OraSure Technologies, which makes diagnostics for HIV and drug use, announced it has settled a patent infringement suit against Schering-Plough. Release

> A recent trial run by BioCryst was negatively impacted by short needles and fat arms. Report

> Sanofi Pasteur is buying into Acambis' program for a novel West Nile vaccine. Report

> Synta Pharmaceuticals' new, $1 billion pact with GlaxoSmithKline for the cancer drug elesclomol (code named STA-4783) is expected to open a spigot of cash for the drug developer. Report

> Nektar Therapeutics got a consolation prize of $135 million from Pfizer--and a fresh shot at signing a new partner--to calm any upset feelings about Pfizer's abandonment of Exubera. Report

And Finally... Book 'em, Danno. A Wyeth sales rep was arrested yesterday for allegedly stealing drug samples and reselling them to pharmacies at a discount. Report

Indian firms to sell generic Trileptal

Wed, 10 Oct 2007 06:59:56 -0400

Two Indian pharma companies got the FDA's approval to sell generic forms of the Novartis epilepsy drug Trileptal. Sun Pharma and Glenmark Pharmaceuticals, both based in Mumbai, are OK'd to market the drug in three different strengths. And because there's no patent litigation to worry about, the products can ship ASAP.

Trileptal is by no means Novartis' top-selling drug, but it does bring in a respectable $640 million in the U.S. annually. Sun and Glenmark share the 180-day marketing exclusivity granted first-in-line generics applications. No word yet on how their pricing will compete with Novartis'--or with each other.

Incidentally, this brings Glenmark's generics tally to 20 in the United States, with 35 more copycat drugs wending their way through the FDA approval process.

- see Sun's release
- here's Glenmark's press release (.pfd)
- read the Sun report from the Economic Times
- read the Glenmark article from the Business Standard

Related Article:
Glenmark clears hurdle for European product launch. Report
Pharma faces "tidal wave" of generics. Report

Read more on: Generic drugs | Sun Pharmaceuticals | Novartis | India

ALSO NOTED: Merck donates Gardasil for poor countries; Caraco gets FDA approval for thyroid drug

Thu, 27 Sep 2007 06:59:50 -0400

> Merck will donate enough doses of its cervical cancer vaccine Gardasil to treat 1 million women in developing countries. Release

> Sun Pharmaceuticals subsidiary Caraco won the FDA's blessing for the thyroid drug Methimazole. Report

> AstraZeneca's dental subsidiary is buying U.S.-based Atlantis Components for $71 million cash. Report

> Solvay Pharmaceuticals says it's cutting its 2010 sales target to €3.2 billion ($4.5 billion) from 3.5 billion, partly because of delays in FDA approval of its schizophrenia drug Bifeprunox. Report

And Finally... Forget drugs--have you chewed your gum today? Report

Roche to Dr. Reddy's: Back off Boniva

Tue, 25 Sep 2007 06:59:56 -0400

Roche has no intention of letting Boniva go gently into that generic night. On the heels of a patent-infringement suit against Teva last week, Roche has sued Dr. Reddy's Laboratories over the osteoporosis drug. And this after acting against Boniva copycats from Apotex and Mutual Pharmaceutical in recent weeks.

Dr. Reddy's has filed for FDA approval for its version of Boniva, but Roche claims the drug is covered by one patent or another through 2023.

- read this article from India Infoline

Related Articles:
Roche, Teva square off in Boniva patent fight. Report
Injectable Boniva approved. Report
Researchers tout once-monthly Boniva data. Report
Roche, GSK outline head-to-head trial of Boniva, Fosamax. Report

Lilly sues Sun Pharma to protect Strattera

Tue, 25 Sep 2007 06:59:55 -0400

Meanwhile, Eli Lilly is waving its torch at Sun Pharmaceuticals to keep the Indian drug maker away from ADHD drug Strattera. The company has already been fighting off two other companies intent on duplicating the drug: Sandoz, Novartis' generics unit; and Actavis Group.

Strattera generated $282 million in sales during the first half of this year.

- read this article from India's Economic Times

Related Articles:
Lilly beset by potential Strattera imitators. Report
Feds to study ADHD drugs for heart risks. Report
Lilly developing biotech drugs the old-fashioned way. Report

Rumor Mill: Indian drug makers court Par

Tue, 18 Sep 2007 06:59:56 -0400

At least three Indian drug makers were spotted with chocolate and flowers at the headquarters of Par Pharmaceuticals, one of the top 10 generics companies in the U.S. Several Indian newspapers are reporting today that Ranbaxy Laboratories, Wockhardt, and Sun Pharma are all three courting the company. The three would-be suitors declined comment.

Curiously, Ranbaxy has already been in the gossip columns about a purported offer for Bradley Pharmaceuticals, which took non-binding bids several weeks ago. And Sun Pharma has agreed to pay $454 million for Taro Pharmaceutical, an Israeli-based generics maker. Is Par Pharma--with a market cap of $692 million--a back-up plan? Well, as they say, all's fair in love and business.

- read this report from India's Economic Times

Related Articles:
Par to restate earnings. Report
Rumor Mill: Dr. Reddy bids for Bradley. Report

ALSO NOTED: Sandoz launches generic Epogen; Sun gets FDA nod for Protonix;

Tue, 11 Sep 2007 06:59:50 -0400

> File in the "Great Timing" drawer: Sandoz says it's launching a generic version of the embattled Amgen drug Epogen in the U.K. and Germany in coming weeks. Report

> Sun Pharmaceuticals got the FDA nod for its generic version of the Wyeth heartburn drug Protonix, which posts annual sales of about $2.3 billion. A federal judge last week refused Wyeth's plea to stop generics companies from making the drug. Report

> Abraxis Pharmaceutical Products got a tentative thumbs-up from the FDA for its generic form of Kytril, which treats side effects of cancer therapy. Report

> Upstart Validus Pharmaceuticals has bought the rights to the bipolar disorder drug Equetro, aka carbamazepine, from Shire. It's part of Validus' strategy of buying and/or licensing mental health drugs that it thinks have been underutilized. Report

> Generics maker Actavis has filed for certification of a copycat version of King Pharmaceuticals' Avinza, technically covered by a patent that doesn't expire till 2017. Report

And Finally... Morphine gives the Japanese heebie-jeebies: Doctors think it's too addictive for use except by the dying, and patients fear it because it's associated with death. Article

Wyeth loses a round to Protonix knockoffs

Fri, 07 Sep 2007 06:59:55 -0400

Wyeth took a blow in federal court yesterday, when a judge denied a preliminary injunction that would have kept generics makers from selling their own versions of the blockbuster heartburn drug Protonix. Wyeth stock dropped on the news, and Citigroup downgraded the shares from "buy" to "hold" because of it.

Both Teva Pharmaceutical Industries and Sun Pharmaceuticals are vying to launch generic Protonix, Wyeth's third best-selling drug with $2.5 billion in sales for the 12 months ended June 30. Teva got the go-ahead for its version last month; Sun expects to hear yea or nay soon. Technically, the Protonix patent doesn't begin expiring until 2010, but Teva has been fighting Wyeth over the protections since 2004. Teva says it will analyze the new court decision before proceeding full-tilt with a Protonix launch--at least that's one bit of this news that Wyeth can be happy about.

- check out the release from Wyeth
- see report from Dow Jones
- read the Forbes article on the financial aftershocks

Related Article:
Wyeth stumbles badly trying to develop new drugs. Report

Ranbaxy, Sun race to generic Razadyne

Thu, 30 Aug 2007 06:59:55 -0400

Who's first out of the gate on a generic Razadyne? Indian drug maker Ranbaxy announced today that it got the FDA's tentative nod for its version of the dementia treatment--but so did Sun Pharmaceuticals, also of India. Ranbaxy also said it "anticipates" the 180-day exclusive marketing window automatically awarded to first-dibs generics makers. No word, however, from the FDA on which company actually will win that privilege.

Ranbaxy says it expects final approval for its version in December 2008. Annual sales of Razadyne, made by Ortho-McNeil, now amount to $130 million.

- see this release from Ranbaxy
- here's the news on Sun's announcement from Moneycontrol

Related Articles:
FDA backlog slows generic drug approval. Report
Ranbaxy reportedly near $100M generics deal. Report
Pfizer, Ranbaxy get mixed ruling in Lipitor patent fight. Report
Patent 'cliff' looms for Big Pharma. Report