Barr Pharmaceuticals

Teva and Barr settle patent dispute

Calisha Myers — Wed, 19 Nov 2008 11:05:14 -0500

Albany Molecular Research (AMRI) announced this morning an agreement with Teva Pharmaceuticals and Barr Laboratories to settle patent infringement litigation. The settlement involved the U.S. dispute over Allegra and Allegra D-12 between Teva, Barr and Sanofi-Aventis.

The settlement will result in an amended licensing agreement between AMRI and Sanofi-Aventis, which will allow Sanofi-Aventis to sublicense the patents to Teva and Barr. Sanofi-Aventis will pay ARMI $10 million in sublicensing fees.

Sanofi-Aventis will continue to pay royalties to AMRI for the products, as well as for authorized generics, for the remaining term of the patents, but sales of products outside of the United States will be unchanged. The royalties will be on all products containing fexofenadine hydrochloride, or combinations of fexofenadine hydrochloride and pseudoephedrine hydrochloride, generic ingredients in Allegra and Allegra D-12.

While the settlement protects patents only having to do with companies in the current litigation, there will be ongoing patent infringement litigation for other makers of generics in the U.S. and abroad.

- view the AMRI release
- check out the Teva release
- see what Barr had to say
- read the story in the Wall Street Journal
- see what BusinessWeek said

Related Articles:
Courts more open to patent-busting
Patent 'cliff' looms for Big Pharma (May 2007)

Generics makers anticipate Obama boon

Tracy Staton — Thu, 06 Nov 2008 11:10:47 -0500

Already generics makers are crowing about a potential boost from an Obama administration. Teva Pharmaceutical Industries CEO Shlomo Yanai told Reuters yesterday that the new president can only help his company, which is the largest maker of copycat meds in the world. And election night, Barr Pharmaceuticals CEO Bruce Downey said he expects the next four years to be a "positive environment" for generics.

Why? Well, in a video interview excerpted by Wall Street Nation, Downey said President-elect Obama is very "pro-generic." He supports generic substitution for branded drugs. He supports legislation that would create a pathway for generic biologics. And he supports strengthening the FDA's generics office, which has come under criticism for allowing generic apps to stack up. Plus, Obama's health plan--if it gets anywhere in this economic crisis--would expand health insurance coverage, boosting drugmakers. "For us, more insurance coverage equals more sales," Downey pointed out.

As you know, Barr is in the process of being acquired by Teva. And as if to emphasize their CEOs' words, both companies reported sales growth today. Teva posted a 21 percent increase in profits to $637 million on a 20 percent rise in revenues to $2.84 billion. Part of that big growth came from a branded drug, Teva's multiple sclerosis treatment Copaxone. Barr announced that sales jumped to $737 million from $602 million, beating analysts' estimates. Adjusted earnings grew to 83 cents a share from 71 cents.

Teva's report on FDA apps also underscored Downey's comments about the agency: The Israel-based company has 145 generics drug apps cooling their heels at FDA, awaiting regulatory approval.

- see the Downey interview at Wall Street Nation
- check out Teva's earnings
- here are Barr's results

Barr, Teva merger poised for tax-free status

Christe Bruderlin-Nelson — Wed, 20 Aug 2008 03:36:13 -0400

The tax gods were with Barr Pharmaceuticals and Teva Pharmaceutical Industries: They recently cleared some IRS requirements to have their merger deal defined as a reorganization with tax-free status.

That's quite a boon for Teva and Barr, who started the merger process in July. Barr stock will be converted into 0.6272 shares of Teva stock plus $39.60 in cash. New Jersey-based Barr will become a domestic subsidiary of Jeruselum-based Teva and the deal is expected to close later this year.

To gain tax-free status, the acquisition must meet criteria under Section 368(a)(1)(A) and Section 368(a)(2)(D) of the IRS tax code--in addition to "Helen of Troy" rules related to foreign transactions--but it seems likely it will pass these and other required tests.

Meanwhile, the companies might just need the tax break, as Barr's first quarter results didn't quite hit the mark.

--read about it at Zacks
--see more at CFO.com

Amgen sues Barr over generic Sensipar

Christe Bruderlin-Nelson — Wed, 30 Jul 2008 10:04:12 -0400

Barr Pharmaceuticals confirmed that its subsidiary, Barr Laboratories, will go head to head with Amgen in a patent challenge process under the Hatch-Waxman Act.

Brigham and Women's Hospital, NPS Pharmaceuticals and Amgen took action to prevent Barr from marketing a generic version of the Sensipar tablets--which come in 30-, 60- and 90-mg tablets aimed at treating hyperparathyroidism--by filing suit in the U.S. District Court for the District of Delaware on Friday. The medication brought in well over $350 million in sales over the last year.

When people have hyperparathyroidism, their parathyroid glands (which are adjacent to the thyroid gland) produce too much parathyroid hormone, causing difficulties with calcium regulation.

Barr put in an Abbreviated New Drug Application (ANDA) with a paragraph IV certification request for a generic version of the drug with the FDA in March. The FDA deemed the application acceptable, but has not made a decision thus far.

- read the report from Forbes
- see the CNN Money article
- get the latest at MarketWatch

It's Teva plus Barr in a $7.46B buyout

Tracy Staton — Fri, 18 Jul 2008 08:42:37 -0400

It's official: Teva and Barr are getting hitched. It's a $7.46 billion cash-and-stock deal that will combine the world's largest and fourth-largest generics makers into one big copycat drug powerhouse. Teva will get added strength in Central Europe and in fast-growing Eastern-European markets. And, as the Wall Street Journal notes, it will expand not only Teva's portfolio of generics, but its branded drug business. Barr has first-to-market rights for several new generics over the next few years, and it has a strong set of branded women's health meds. Plus, it will vault Teva forward in its strategic plan to reach $20 billion in sales with a 20 percent margin by 2012.

Under the terms of the deal, Barr's common stock will be converted to cash and Teva ADRs at a per-share rate of $39.90 and .6272 of an ADR, valuing Barr at $66.50. That's a 42 percent premium over Wednesday's price and a 16 percent premium to Thursday's--which includes a big jump in value on rumors of the takeover. Teva also will assume $1.5 billion of Barr's debt.

Just how big of a generics maker might the combined companies represent? Pro forma, 2007 revenues would have been about $11.9 billion. And together, the two companies would operate in more than 60 countries. In a note to investors before the official announcement, Goldman Sachs said a deal in the $8 billion range would quickly add to Teva's earnings on a cash basis. But, the analysts said, combining with Barr would give Teva more exposure to the U.S. market, where growth is expected to slow.

- check out Teva and Barr's release
- read the WSJ story
- see the news from the Associated Press
- get more on the financial side from Portfolio
- find Goldman's investor note in Barron's

Rumor mill: Teva mulling $7.5B deal for Barr

Tracy Staton — Thu, 17 Jul 2008 09:56:29 -0400

The world's biggest generics firm may be about to get bigger--a lot bigger. Teva is reportedly in talks to buy Barr Pharmaceuticals for upwards of $5 billion; some reports quote a price as high as $7.5 billion. The latter figure would be a 50 percent premium for Barr, which closed the regular trading day at $46.82 but after hours leapt 19 percent to $55.51 on the news.

Reports of the negotiations appeared in two Israel dailies, and a UBS analyst issued a note ticking off reasons a Barr buyout would make sense for Teva: It would give the Israeli company access to the oral contraceptive market, strengthen its European presence and boost efficiencies by "eliminating duplicate infrastructure in the U.S."--which sounds like shutdowns and layoffs to us, but given the fact that no deal's been struck, that's getting the cart before the horse.

This year Teva's already announced a buyout of Bentley Pharmaceuticals, which has a strong presence in Spain, and a deal for CoGenesys, a biotech. Though the company is sitting on some $3.6 billion in cash, a whopper Barr deal would require it to take on more debt and do some kind of equity payment, too, an Israeli investment bank predicted. Teva refused to comment on "market rumors."

- see the story at MarketWatch
- read the Globes article

Barr closer to launching RLS generic

Tracy Staton — Fri, 27 Jun 2008 10:05:41 -0400

Barr Pharmaceuticals said a court backed its patent challenge of Mirapex, Boehringer Ingelheim's treatment for restless leg syndrome; Barr got FDA approval for a generic version in February. Mirapex sales came to $381 million for the 12 months ended in April, IMS Health figures show. Report

Barr, Bayer clinch generic Yasmin deal

Tracy Staton — Tue, 24 Jun 2008 09:24:06 -0400

Another generic deal that antitrust watchdogs love to hate: Barr Pharmaceuticals inked a deal to sell an "authorized generic" version of Bayer's birth control pill Yasmin by July 1, several years before the product's last patent expires. Barr also will launch an authorized copycat of Bayer's Yaz product on July 1, 2011. In both instances, Barr gets exclusive rights to sell the meds in the U.S., and Bayer will supply the pills. In return, Bayer will get a share of the sales.

You'll recall that in March, a federal court deemed one of Yasmin's key patents invalid. Bayer is appealing that decision. Even if Bayer wins, though, Barr will still get to sell generic Yasmin. It will just have to pay a larger share of sales to Bayer for the privilege.

- check out the release
- read the Associated Press story
- see the coverage in Forbes

ALSO NOTED: Apotex assails Canadian goodwill drug program; Amgen CEO: "I felt real economic pain";

Fri, 09 May 2008 06:59:50 -0400

> After winning a bid to produce and ship generic AIDS drugs to Rwanda, Apotex says it won't participate in the goodwill program again unless the Canadian government simplifies the process. Report

> What do you do when your biggest therapeutic earners are swooning, your stock price is down and analysts have turned scornful? Look for that silver lining. That was Amgen's CEO Kevin Sharer's approach yesterday when he was confronted by an angry horde of shareholders at the company's annual meeting. Report

> FDA chided Shire for distributing Fosrenol promotional materials that fail to include information on the drug's indication and risks. Report

> India's FDA got FDA approval for its glaucoma treatment. Report

> Quintiles Transnational said it had agreed to buy Eidetics, a decision-analytics and market research firm, as a bid to expand its pharmaceuticals consulting business. Report

> FDA gave its blessing to the atypical antipsychotic Abilify as an add-on treatment for bipolar disorder, Bristol-Myers Squibb and partner Otsuka Pharmaceutical announced. Release

> Astellas Pharma won European approval for Mycamine, its antifungal drug. Release

> Germany's Gruenenthal announced it would add $76 million to its trust fund set up in the 1970s to compensate thalidomide victims. Report

Earnings News

> Weak U.S. sales depressed Barr Pharmaceuticals' first-quarter profits as the company faced surprise competition on a new generic of Fosamax, Merck's osteoporosis drug. Contraceptive sales also fell short. Report | Report

> Japan's Takeda posted a 5.9 percent hike in profits for its year ended March 31, but said its purchase of Millennium Pharmaceuticals will put a damper on the new fiscal year's earnings. Report

> Hungarian drugmakers Richter Gedeon announced a 41.7 percent increase in first-quarter profits to $62.25 million, but it cut its sales forecasts for the U.S. and Hungarian markets. Report

> Warner Chilcott posted net income of $33.7 million on a 5.1 percent increase in revenues to $229.5 million. Release

> Weak sales of its allergy drug Elestat depressed Inspire Pharmaceuticals' first-quarter results, leading to a $25.9 million loss that disappointed Wall Street. Report

Biotech News

> Backed by a positive review from FDA staffers, an expert panel at the agency has recommended the agency approve Eisai's fospropofol disodium, a sedative designed for use in a number of procedures. Eisai report

> Eli Lilly has won FDA approval of Strattera, a therapy designed to treat ADHD. Lilly says this is the first regulatory win for a non-stimulant ADHD drug in a market dominated by two stimulants--Adderall (Shire) and Ritalin (Novartis). Report

> The life sciences equipment maker Millipore is looking extra green today. The company announced plans to reduce its carbon footprint by 20 percent. Millipore report

And Finally... The Financial Times delves into the push to develop new therapeutics from traditional Chinese and Indian remedies. Report

ALSO NOTED: High-dose Celebrex triples heart risk; Actos slows plaque buildup in arteries;

Tue, 01 Apr 2008 07:59:50 -0400

> Patients taking the largest dose of Pfizer's painkiller Celebrex, 400 mg twice a day, tripled their chance of heart attack or stroke compared with placebo, according to a new study presented at the American College of Cardiology meeting. Report

> Takeda's Actos slowed the progression of arterial plaque buildup, becoming the first type 2 diabetes med to reduce progression of coronary atherosclerosis, a new study showed. Report

> Stunned by a report that doctors are needlessly prescribing brand-name drugs, France is considering setting up a force of 1,700 anti-drug reps to counteract sales pressure with "objective" information. A bill that would set up a similar force in the U.S. is pending in Congress. Report

> ING started its analyst coverage of GlaxoSmithKline with a 'buy' rating and a prediction that new CEO Andrew Witty would bring a fresh strategic approach to the company. Report

> Doctors called Merck's online promotions the best of their kind, with GlaxoSmithKline coming in second, a Verispan survey showed. Report

> Boston Scientific is selling off its endovascular aortic repair program for $30 million to a Santa Rosa, CA-based investor group. Report

> Dr Reddy's Laboratories has agreed to buy part of Dow Chemical's pharmaceuticals business in a bid to boost its custom manufacturing services. Report

> Pliva CFO Ivan Mijatovic has been appointed senior vice president for corporate development of parent company Barr Pharmaceuticals. Report

> Medco Health Solutions is partnering with the Swedish government on a prescription review program designed to prevent medication errors. Report

> Struggling to right itself after a long dry spell in new drug approvals, Eli Lilly is preparing to a launch a late-stage study of an experimental drug for Alzheimer's. Report

> In a head-to-head study, the new antiplatelet drug prasugrel (being developed by Lilly and Daiichi Sankyo) in combination with aspirin outperformed the standard therapy, clopidogrel (Plavix) with aspirin. Report

> In a possible boon to the biotech industry, the SBA is looking to hike research grants to small U.S. businesses. Report

And Finally... Scientists are studying whether fasting can protect healthy cells against chemotherapy, making cancer treatment more effective. Report

ALSO NOTED: Barr gets FDA's blessing for generic Taxol; Biovail founder wants to reform company's board;

Thu, 13 Mar 2008 07:59:50 -0400

> Barr Pharmaceuticals got the FDA's final nod for its generic version of the Bristol-Myers Squibb cancer med Taxol. Report

> Biovail founder and minority shareholder Eugene Melnyk (photo) says he plans to propose changes to the company's board in the wake of a fourth-quarter loss of $32 million. Report

> Bentley Pharmaceuticals posted a 28 percent hike in fourth-quarter revenues. Report

> Abbott Laboratories got FDA approval for an implant that continually tracks blood sugar. Report

> In February the FDA approved nine first-time generic meds, including versions of the osteoporosis med Fosamax, the cancer drug Camptosar, and the heartburn remedy Pepcid Complete. Chart

> Wyeth and Progenics were handed a serious blow yesterday when their intravenous drug methylnaltrexone for postoperative ileus flunked the first of two Phase III trials. Report

> An expert panel will weigh in on Amgen's Nplate. Report

> An FDA committee has unanimously recommended Schering-Plough's sugammadex for approval. Report

> In 2007, there was much ado about the slow pace of new molecular entity (NME) approvals. Though over 200 drugs were approved in 2007, only 19 of them represented groundbreaking advances in medicine. In 2008, according to a post on Pharmalot, the industry is set to repeat last year's lackluster performance. Report

And Finally... Life expectancy in the U.S. is rising, but only among people with more than 12 years of education. Release

ALSO NOTED: Government could force doc disclosures; Barr sues Watson over Seasonique patent;

Thu, 06 Mar 2008 06:59:50 -0500

> The government is considering requiring pharma companies to disclose their doc-consulting deals as part of any settlement agreements. Report | Report

> Duramed, a Barr Pharmaceuticals subsidiary, filed a patent infringement suit against Watson Pharmaceuticals, alleging it had infringed on its patent for the contraceptive Seasonique. Release

> Teva sued the FDA for denying its exclusivity period for its version of the antipsychotic Risperdal, which goes off patent this year. Release

> Genzyme launched its phosphate-binding drug Renvela for use in dialysis patients in the U.S. Release

> Baxter may test its immune booster Gammagard against Alzheimer's after a medical claims analysis indicated the risk of developing the disease could be reduced in patients previously treated with the med. Report

> A new study showed that Novartis' cancer drug Gleevec could harm fetal development if the child was conceived during treatment. Report

> With no "firm" buyout offers coming in, PDL BioPharma has decided to axe 260 workers--on top of the 320 layoffs already announced--and take itself off the market. Report

> After concluding that its late-stage trial of MC-1 failed to hit its primary endpoint, Medicure has announced plans to slash 50 workers and full-time consultants. Report

> The FDA is sending signals that it will start to let deadlines for drug approvals go by the wayside. Report

And Finally... Surgery may effectively cure Type II diabetes, according to a new study in Diabetes Care. Report

Bayer loses Yasmin patent fight

Tue, 04 Mar 2008 06:59:57 -0500

Bayer had the Yasmin rug pulled out from under it yesterday. A U.S. court voided the contraceptive's key patent, leading the German conglomerate to revise its 2008 profit expectations downward. Until now, Yasmin and related meds were Bayer's top sellers, just ahead of its MS treatment Betaseron.

The ruling opens the door for Barr Pharmaceuticals to sell a Yasmin copycat in the U.S. The product sold $487 million worth here last year; including other, sister meds such as the lower-dose version Yaz, the franchise is worth about €1 billion, or $1.5 billion. Bayer is mulling an appeal; regardless of the ruling, it holds exclusivity on the drug till 2009.

It's just the latest in a series of blows for Bayer, which last month saw its drug Nexavar fail a lung cancer trial. Last fall, the company suspended sales of its anti-bleeding med Trasylol because of side effects.

- see Barr's release
- read the report from Forbes
- check out the BusinessWeek coverage

Related Articles:
Yasmin sales spur earnings at Bayer. Report
Bayer lower 2008 expectations. Report

ALSO NOTED: Pro-compulsory license official reassigned in Thailand; Galderma to nab CollaGenex for $420M

Wed, 27 Feb 2008 06:59:50 -0500

> Thailand's FDA chief was transferred to an "inactive post" in a move observers consider linked to the government's rethinking of previous officials' policy of quashing cancer-drug patents. Report

> Dermatology drugs specialist Galderma Pharma said it has agreed to buy CollaGenex Pharmaceuticals for $16.60 per share cash, or $420 million. Report

> Barr Pharmaceuticals reached a $6 million settlement with Iowa and 33 other states that sued the company for agreeing not to launch a generic version of the Warner Chilcott contraceptive Ovcon. Report

> The U.K.'s drug advisory panel says children as young as 12 should get nicotine patches if they have a serious smoking problem. Report

> NPS Pharmaceuticals said its president and CEO Tony Coles would step down to become president and CEO of Onyx Pharmaceuticals; he will be succeeded at NPS by EVP and COO Francois Nader. Report

> More bad news on the big drought of new drug approvals. Not only are approvals at a 25-year low while non-approvable letters and black box warnings are on the rise. Now "refuse-to-file" letters are also spiking. Report

And Finally... One in 20 tuberculosis cases worldwide is now resistant to two or more drugs, and an extensively resistant form is active in 45 countries. Report

FTC sues Cephalon for blocking generics

Thu, 14 Feb 2008 06:59:57 -0500

Here's one way generics might pay off. The feds are accusing Cephalon of bribing drugmakers to keep copycat Provigil off the market. According to an FTC lawsuit against the company, Cephalon paid four generics makers $200 million to stop selling their versions of the narcolepsy drug until 2012. With $800 million in annual sales, Provigil accounts for about half of Cephalon's revenues.

Using words like "monopoly," an FTC official said Cephalon agreed to share profits with the generics firms in exchange for their staying out of the fray. "Such conducts is at the core of what the antitrust laws proscribe," the official said. But Cephalon defended its agreements with the other companies, which settled patent litigation. "We believe they fully comply with both the spirit and letter of the antitrust laws," the company said in a statement. And Barr Pharmaceuticals, one of the generics firms, said that it believes the deals are legal and that they serve consumers' best interests.

- find Cephalon's release about the FTC suit
- read the story in BusinessWeek
- check out more details in the Wall Street Journal

Related Articles:
Cephalon to pay $425M settlement. Report
Cephalon takes heat for off-label narcotic promotion. Report

ALSO NOTED: Teva, Barr get OK to sell Fosamax copies; Ranbaxy wins FDA nod for copycat Nexium;

Thu, 07 Feb 2008 06:59:50 -0500

> Teva and Barr Pharmaceuticals both got FDA approval for their generic versions of Merck's osteoporosis drug Fosamax, which went off patent yesterday. Report

> India's Ranbaxy got the tentative FDA nod for its copycat form of AstraZeneca's Nexium heartburn pill, which is still under patent. Report

> Millennium Pharmaceuticals posted fourth-quarter profits of $41.06 million on revenues of $181.19 million. Report

> Wyeth hired Timothy Cost to be senior vice president for corporate affairs; previously, cost handled corporate affairs at ARAMARK. Report

> Swiss-based Octapharma is moving its U.S. headquarters to a 15,000-square-foot facility in Hoboken, NJ. Report

> Biogen Idec reported a big boost in quarterly profits, largely due to strong sales of its multiple sclerosis drugs and a cancer med it markets jointly with Genentech. Report

> French authorities are investigating GlaxoSmithKline and Sanofi Pasteur over an anti-hepatitis B vaccination campaign in the 1990s. At issue is whether the companies fully disclosed the shot's potential side effects. Report

> A new blend of a genetically modified chimp adenovirus and a malaria gene is proving promising as a potential vaccine against malaria. Report

> Speculation over the prospective acquisition of CeNeS continued to mount as the company's shares shot up 70 percent yesterday. Report

> AstraZeneca is shaking up its global R&D efforts, planning to slash some 300 research positions at a major complex in the U.K. Report

> The most efficient drug development programs will rely on contributions from a variety of companies, with partnerships and outsourcing providing unique expertise to advance new therapies, according to a new study from Tufts Center for the Study of Drug Development. Report

And Finally... Prescription mac-and-cheese? Kraft Foods is working on products that will contain plant oils to kill intestinal parasites such as tapeworms. Report

ALSO NOTED: J&J expects global sales to goose profits; Pfizer's lower earnings still beat analysts;

Wed, 23 Jan 2008 06:59:50 -0500

> Johnson & Johnson surprised onlookers with a rosy earnings outlook for 2008, predicting up to a 7 percent increase in profits on growth in international sales. Report

> Though Pfizer's fourth-quarter earnings fell to $2.9 billion, 70 percent less than the same period last year, the company still beat analysts' expectations; full-year sales were up, but only by 1 percent, to $48.6 billion. Release

> The FDA gave the nod to new uses for Mycamine, Astellas Pharma's anti-candida drug; previously approved for infections in the esophagus, the med can now be used against candida in other parts of the body, too. Release

> The U.K.'s National Institute for Health and Clinical Excellence agreed to pay for Eli Lilly's lung cancer drug Alimta when used against mesothelioma, a type of cancer caused by asbestos exposure. Report

> Barr Pharmaceuticals is in settlement talks with Ortho Women's Health & Urology, hoping to resolve a patent dispute over Ortho Tri-Cyclen Lo, an Ortho birth control pill. Report

> California's efforts to track prescription drugs to combat global counterfeiting may be delayed to 2011 to allow drug makers more time to get the computer systems needed to keep tabs on individual bottles of drugs. Report

> India's Nicholas Piramal is buying the Bangalore-based parenteral maker Healthline for $3.8 million, planning to seek FDA approval for its manufacturing facilities. Report

> Managed care pharmacy execs ranked Novartis as number one drugmaker for the eleventh time, with Merck at number two and Schering-Plough at number three. Report

> A research team at Genentech has identified two new genes that are linked to lupus, further advancing the biotech giant's work to identify new ways to identify and treat patients with the disease. Report

> An international research consortium is launching the 1,000 Genomes Project, mapping the genomes of a thousand different people in an effort to shine a bright research light on the influence of genetic variations on disease. Report

> In a move that could have far reaching influence over the scale of pay for young researchers, the prestigious Whitehead Institute for Biomedical Research has significantly increased the wages earned by postdocs. Report

> Just days after scornfully assessing a field of weak-kneed pharma companies that were too timid to see the real value in Biogen Idec, the CEO says he may be in the market for a $10 billion acquisition himself. Report

> U.S. biotech and medical device companies raised a record $9.1 billion last year, 20 percent more than the year before. Report

And Finally... Researchers are proposing an overhaul of the way consumers pay for prescription drugs for chronic conditions. Report

Merck joins Fosamax copycats

Mon, 14 Jan 2008 06:59:55 -0500

Merck won't be outdone on Fosamax. The company has struck a deal with an unidentified generics supplier for an authorized, copycat form of the osteoporosis drug. The Merck-blessed generic could go on sale as early as next month.

You'll recall that Fosamax's key patent is due to expire Feb. 6, and two generics makers--Teva Pharmaceutical Industries and Barr Pharmaceuticals--are first in line. Because they were first to ask the FDA for approval for their versions of Fosamax, they have six-month exclusivity. But that exclusivity doesn't apply to Merck itself, which could sell its own generic form or do so with a partner.

This type of arrangement--for an authorized generic--has come under fire as more and more pharma companies have begun to engage. Critics say they destroy the competitive advantage that six-month exclusivity is designed to confer; now, the Federal Trade Commission is studying the deals

- read the Wall Street Journal article

Related Articles:
US Senate to take on authorized generics. Report
Merck expects $1.8B hit on Fosamax. Report
Merck touts Fosamax data. Report
Merck profits jump by 62 percent. Report

Analysts get bullish on generics makers

Wed, 19 Dec 2007 06:59:57 -0500

The flip side of Big Pharma's angst over generic competition is growing exuberance about generics makers. Early this week, the Wall Street Journal tipped off investors to Indian generics companies' waxing fortunes. Yesterday, several major generics makers saw sizable stock gains. Meanwhile, individual companies are attracting analyst kudos:

Teva Pharmaceutical got an "outperform" rating from Cowen & Co., which predicted a strong 2008, marked by the exclusive launch of a copycat Risperdal, plus possible shared exclusivity on generic Wellbutrin XL, Lamictal, and Fosamax.
A Banc of America Securities analyst started covering Teva, Mylan, and Barr Pharmaceuticals, rating each a "buy." He called Teva a "Best in Class Generic," setting a price target of $55 on its stock, which currently is trading at around $45. Mylan got an $18 target (its current share price is $13.77), on the strength of three big launches next year. And he cited Barr for its 70 drug apps pending at the FDA.

The WSJ's focus on Indian generics makers emphasized that their stocks have "taken a beating" recently, so they're starting to look cheap. Plus, several companies are on a growth spurt; the country's biggest drug maker, Ranbaxy, for instance, is expected to grow earnings by 41 percent next year.

- read the Wall Street Journal's bullish generics article
- get more on Cowen's report on Teva
- see the Banc of America report

Related Articles:
Patent 'cliff' looms for Big Pharma. Report
Generic competition heats up. Report
Drug lobby stalls pro-generics bill. Report
Say goodbye to Big Pharma's gilded age. Report

ALSO NOTED: Japan to get Roche's Tarceva next week; Barr sues two generics makers over Seasonale;

Fri, 14 Dec 2007 06:59:50 -0500

> Roche's Japanese unit Chugai Pharmaceutical is preparing to launch the lung-cancer drug Tarceva, approved in Japan in October for treatment of the non-small cell form of the disease. Report

> Barr Pharmaceuticals sued Watson Pharmaceuticals and Sandoz for infringing the patent on Seasonale, a birth control product made by Barr's Duramed unit. Report

> The FDA gave its blessing to Kuvan, a BioMarin Pharmaceutical drug designed to treat the genetic disorder phenylketonuria. Report

> Isis Pharmaceuticals promoted B. Lynne Parshall to chief operating officer; she'll also retain her position as CFO and director. Release

> Forest Laboratories announced that several companies are seeking approval to sell copycat forms of its Alzheimer's drug Namenda. Report

> GlaxoSmithKline is sinking $100 million into a neuroscience research center in China that will play a pivotal role in its ongoing drug discovery work. Report

And Finally... For protection, HIV and aggressive cancer cells cloak themselves in carbo-clothing worn by human sperm. Report