Pliva

Actavis to buy Abrika Pharma in $238M deal

Wed, 29 Nov 2006 19:01:34 -0500

Iceland's generic drug maker Actavis has agreed to buy Abrika Pharmaceuticals in the U.S. for up to $238.5 million. Actavis will make an initial payment of $110 million in cash and up to $125 million based on its performance over the next three years. Actavis says the deal will make it a leader in the U.S. for controlled-release drugs. The Icelandic company recently lost a bidding war with Barr for Croatia's Pliva.

- here's the report on the buyout

Related Article:
Actavis buys ZiO Zdorovje for $60M. Report
Actavis ups ante in bidding war for Pliva. Report

ALSO NOTED: Neurogen licenses Wyeth drug; Pliva gets generic approval; and much more...

Mon, 27 Nov 2006 19:01:30 -0500

> Neurogen has paid $3 million as an initial licensing fee for Wyeth's Applindore. Wyeth had been developing Applindore as a treatment for schizophrenia, but Neurogen says it will focus on the drug as a treatment for Parkinson's disease. Report

> Pliva has obtained FDA approval to market a generic version of BMS' cholesterol drug Pravachol. Report

> Phytomedics has announced positive results for a phase II clinical trial of PMI-001 in patients with either new onset or therapy-resistant rheumatoid arthritis. Release

> FDA staffers have raised questions about design limitations that they say may influence the effectiveness of Celebrex in children. An FDA advisory committee will meet tomorrow to consider approving Celebrex for children as young as 2. Report

> Angiotech Pharmaceuticals plans to sell $325 million in senior notes. Report

And Finally... An epidemic of asthma has stumped experts on the possible cause. Article

Press Release: Barr's Subsidiary PLIVA Receives Approval for Pravastatin Tablets

Maureen Martino — Mon, 27 Nov 2006 08:06:25 -0500

Barr's Subsidiary PLIVA Receives Approval for Pravastatin Tablets 10mg, 20mg, and 40mg and Tentative Approval for 80mg

WOODCLIFF LAKE, N.J., Nov 28, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) and its subsidiary PLIVA d.d. (LSE: PLVD; ZSE: PLVA-R-A) today announced that PLIVA has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market Pravastatin Tablets 10mg, 20mg, and 40mg, the generic version of Bristol-Myers Squibb's PRAVACHOL(R) (Pravastatin Sodium) Tablets. The Company plans to launch its product immediately. PLIVA has also received tentative approval for its Pravastatin Tablets 80mg strength and plans to launch this strength following the expiration of a competitor's 180-day generic drug exclusivity period and subsequent final approval of PLIVA's application.

Pravastatin is indicated for the primary prevention of coronary events in hypercholesterolemic patients without clinically evident coronary heart disease, and secondary prevention of cardiovascular events in patients with clinically evident coronary heart disease. Pravastatin Tablets 10mg, 20mg and 40mg compete in a market that had total U.S. sales of approximately $1.2 billion, based on IMS data for the 12-month period ending September 2006.

About Barr Pharmaceuticals, Inc.

Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Company markets more than 120 generic and 25 proprietary products in the U.S. and more than 550 products globally outside of the U.S.

Forward-Looking Statements

Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non-infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies (including PLIVA d.d.) and products we acquire and implementing our new enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; our expansion into international markets through the completion of the PLIVA acquisition, and the resulting currency, governmental, regulatory and other risks involved with international operations; our ability to service our increased debt obligations as a result of the PLIVA acquisition; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2006.

The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.

SOURCE Barr Pharmaceuticals, Inc.

ALSO NOTED: Ariad selling shares; Indevus gains milestone; Barr closing on Pliva; and much more...

Thu, 19 Oct 2006 20:01:30 -0400

> Ariad Pharmaceuticals is selling 3.1 million shares in a public offering. Report

> Indevus Pharmaceuticals has received a $10 million milestone payment from Esprit Pharma, the company's partner in the U.S. for Sanctura and and Sanctura XR. Release

> Barr Pharmaceuticals has now acquired 92 percent of Pliva's shares, putting it on track to close the takeover next month. Report

> Dutch biotech AM-Pharma is touting positive results for its pilot study in treating sepsis with its Alkaline Phosphatase drug. Release

And Finally… Scientists helped add 30 years to the average life span over the past century. Now they're focusing on adding vitality to a longer life. Report

Barr gains majority of Pliva shares

Tue, 10 Oct 2006 20:01:34 -0400

Barr Pharmaceuticals would appear to have won the battle for Croatia's Pliva with its announcement that it has acquired more than 70 percent of the drug maker's stock. Barr had been in a bidding war with Actavis for control of Pliva. If Barr completes the deal, which seems likely, it will create the world's third largest generic drug maker.

- Here's the article from the International Herald Tribune

ALSO NOTED: Daiichi Sankyo invests in venture fund; ImaRx sets IPO terms; and much more...

Thu, 07 Sep 2006 20:01:30 -0400

> Daiichi Sankyo plans to invest $60 million into a $180 million, 10-year venture fund run by Kearney Venture Partners. The deal allows Daiichi to strike collaborations with the biotech companies who gain funds from the venture group. Release

> ImaRx Therapeutics has set the terms of its IPO of 5 million shares at $10 to $12 each. Much of the $49 million the company hopes to net will go to product development and debt repayment. Report

> Trimeris of Morrisville, NC and Roche have extended their research pact for two distinct peptide classes. Report

> Barr Pharmaceuticals has filed a new offer in the bidding war for Pliva. Report

> The board of Discovery Partners International has approved a four-to-one stock split linked to its merger with Infinity Pharmaceuticals. Report

> Labopharm is preparing to unveil new Phase III safety data for tramadol that it says will support its effort to gain approvals for the pain therapy. Release

And Finally... A new study from Mount Sinai Medical Center resolves any lingering doubt that may exist about the link between the dust kicked up by the World Trade Center attack and persistent illnesses suffered by rescue workers. Article

Actavis ups ante in bidding war for Pliva

Wed, 30 Aug 2006 20:01:37 -0400

Iceland's Actavis has upped its bid to acquire Croatia's Pliva to $139 a share, surpassing the latest offer from Barr. But analysts say the bidding war isn't over yet. They're waiting to see how Barr reacts to this latest bid and many expect yet another higher bid to hit the table. The winner in the bidding war for Pliva will create the world's third largest generic drug maker, behind Teva and Novartis.

- see the AFX report on Actavis' bid

ALSO NOTED: Xyotax trial indicates efficacy; Wyeth encouraged by FDA meeting cancellation;and much more...

Tue, 22 Aug 2006 20:00:50 -0400

> Cell Therapeutics reported that more than half of the patients in a small Phase I dosing study of its cancer therapy Xyotax saw tumors shrink or disappear. Of 12 patients with cancer limited to a local region, four saw tumors disappear and seven had their tumors shrink by more than 50 percent. Report

> Wyeth says its encouraged by a recent decision by the FDA to cancel an advisory committee meeting to discuss its antidepressive desvenlafaxine succinate extended release, saying the agency didn't need the additional input to make a decision. Report

> The board of Croatia's Pliva is backing a $2.3 billion acquisition bid from Barr Pharmaceuticals. Barr has been in a bidding war with Actavis for Pliva. Pliva's board warmly endorsed Barr's plans to boost its operations and hire more staffers. Report

> The FDA has approved the use of Keppra (levetiracetam) as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Release

> An independent data safety board has recommended that YM Biosciences continue its Phase III trial of its tesmilifene breast cancer treatment. Report

> Celera Genomics has won a $900,000 NIH grant to develop a rapid diagnostic test for bird flu. Report

> And Finally… New research indicates that baby boomers who are only modestly overweight still face a significantly higher risk of death. Report

ALSO NOTED: TransPharma raises $18M; Biogen Idec, Elan re-release Tysabri; and much more...

Sun, 23 Jul 2006 20:00:50 -0400

> TransPharma Medical, which is developing a new drug delivery technology, has raised $18 million in financing. Report

> Biogen Idec and Elan have re-released Tysabri for MS in the United States. Report

> Researchers are exploring the effectiveness of a combination of cancer-drug mitoxantrone and copaxone to treat aggressive MS. Release

> Biovail and Athpharma have terminated a development pact for four cardiovascular drugs. Report

> Barr Pharmaceuticals says it is confident that it can meet any requirements the FTC may have as a condition for buying Pliva. Report

> Nektar Therapeutics announced that it received $17.6 million from Affymax for a previously undisclosed licensing deal. Report

And Finally… Scientists at the Max Planck Institute for Evolutionary Anthropology plan to crack the genetic code of Neanderthals in order to better understand why they became extinct while modern man thrived. Article (WSJ sub. req.)

SPOTLIGHT: FDA lifts Pliva block

Thu, 06 Jul 2006 20:01:33 -0400

Pliva announced that the FDA had given it a green light to ship three pharmaceuticals from its Zagreb plant after the company took corrective action on the agency's May warning letter. Report

DEALS: J&J buys Pfizer's OTC division for $16.6B

Wed, 05 Jul 2006 20:01:32 -0400

J&J buys Pfizer's OTC division for $16.6B

DEALS
WHO	WITH	WHAT	SCOOP
Pfizer	Johnson & Johnson	$16.6B sale	Pfizer has sold its OTC division to J&J for $16.6 billion in cash.
Siemens	Bayer Healthcare	$5.3B buyout	Siemens has purchased the diagnostics division of Bayer Healthcare. The move is expected to help Bayer complete the acquisition of Schering.
Barr Pharmaceuticals	Pliva	$2.2B buyout	Barr Pharmaceuticals beat out Actavis Group when generic drug maker Pliva announced that it accepted Barr's $2.2 billion buyout offer.
Johnson & Johnson	Vertex	Collaboration deal	The companies will collaborate to develop VX-950 for hepatitis C. Vertex gains $165 million and up to $380 million in milestone payments.
Takeda	Affymax	$535M deal	Takeda will pay Affymax up to $535 million for the worldwide rights--excluding Japan--to Hematide, a therapy for anemia in cancer and kidney disease patients.
Sanofi-Aventis	Taiho	$360M deal	The deal is for most of the global rights to Taiho's S-1 cancer therapy for colorectal, head and neck cancer
Johnson & Johnson	Metabolex	Licensing deal	Johnson & Johnson is buying into Metabolex's program for diabetes and other metabolic conditions with a new collaboration pact that provides a $40 million equity stake and up to $508 million in milestones.
Mayne Pharma	SuperGen	Licensing deal	Mayne has bought North American rights to the leukemia drug Nipent and a medical surface cleaner from SuperGen for $15 million up front and up to $19 million in milestone payments.
Skyepharma	Mundipharma International Holdings	$5M licensing deal	Skyepharma bought back European rights to DepoBupivacaine for its experimental pain drug DepoBupivacaine.
Eli Lilly	Inpharmatica	Licensing deal	Eli Lilly has licensed Admensa Interactive, Inpharmatica's suite of predictive drug absorption, distribution, metabolism and excretion (ADME) models and compound prioritization tools.

ALSO NOTED: New warning added to Aptivus; Novartis increases NeuTec control; and much more...

Sun, 02 Jul 2006 20:00:50 -0400

> The warning on the AIDS drug Aptivus is being updated to include a warning that the drug has been linked to sometimes fatal cases of bleeding in the brain. Report

> Novartis has acquired 8.3 percent of NeuTec, bringing its total to 52 percent as it pursues plans to buy the British biotech. Report

> Japan's Astellas Pharma has picked three drugs in its pipeline for rapid development. Report

> Quantum Genomics of Jersey City, NJ has opened its European headquarters near Paris. Release

> Pfizer is cutting the price of some drugs that have lost patent protection in Switzerland. Report

> The board of Barr Pharmaceuticals says it can win the battle for control of Pliva. Report

And Finally... Scientists are discovering that cloned animals are often dramatically different from their originals. Article

Actavis renews bidding war for Pliva

Thu, 29 Jun 2006 20:01:36 -0400

Ignoring Pliva's endorsement of a buyout offer from Barr Pharmaceuticals, the Actavis Group has upped its bid to $2.3 billion and insists it will win in the end. Actavis has acquired more than 20 percent of Pliva's shares and says that it believes the board will be happy to accept the highest offer for the Croatian generic drug company. If Actavis prevails, it will create the world's third largest generic drug maker, behind Teva and Novartis.

- here's the report on Actavis from the International Herald Tribune

Pliva accepts Barr's $2.2B buyout bid

Mon, 26 Jun 2006 20:01:36 -0400

The Croatian drug maker Pliva has accepted a $2.2 billion buyout offer from Barr Pharmaceuticals, beating out a competing bid from Actavis Group. The winning bid represents a 38 percent premium over the generic drug maker's stock price the day before it announced it would seek a buyer. "Barr is an ideal partner for future growth in this consolidating industry and an excellent strategic fit with Pliva, which we believe will strongly contribute to the global competitiveness of the new Barr Group," said Pliva CEO Zeljko Covic. Pliva sold its R&D division to GSK earlier this year for $50 million.

- here's the AP report on Pliva

ALSO NOTED: Clinphone shares rise on debut; Allergan gets FDA OK for eye drug; and much more...

Thu, 22 Jun 2006 20:00:50 -0400

> Shares of Clinphone, a UK company that assists researchers in managing clinical trials, saw its shares jump 15 percent on its market debut. Report

> The FDA has approved Allergan's once daily Lumigan as a first-line therapy for elevated intraocular pressure. Report

> Shares of Altus Pharmaceuticals were buoyed by positive Phase II data for its once-weekly form of a human growth hormone--ALTU-238. Report

> Pharmaceutical benefit managers and other drug buyers are exacting bigger and bigger discounts for preferred drugs, as drug makers see their position at the bargaining table weakened. Article (WSJ sub. req.)

> Pliva may soon announce the winner in a $2 billion bidding war for the Croatian drug maker. Report

> Scios is laying off 350 workers in Fremont, CA as part of a company realignment. Report

> Sandoz has filed a complaint in court asking that Teva's version of Zocor be delayed until the FDA approves its own copycat drug. Report

And Finally… Illegal tattoos are helping spread a deadly, drug resistant infection. Article

ALSO NOTED: FDA delays Adderall decision;Actavis raises Pliva bid; and much more...

Thu, 20 Apr 2006 20:00:50 -0400

> Shire says that the FDA has told the company that it hasn't been able to make a decision on its concerns that copycat versions of Adderall XR are too easy to produce. Shire wants the agency to require more rigorous bioequivalence testing. Report

> Iceland's Actavis has raised its bid for Pliva by 11 percent. Report

> Omrix Biopharmaceuticals has priced its IPO at $10 a share. Report

> NovaDel has raised $12 million from a stock sale to fund new clinical development work. Release

> Akorn and India's Natco have inked a deal to commercial two injectable therapies. Release

> An updated safety review by Nymox of NX-1207 for benign prostatic hyperplasia has revealed no serious side effects. Report

> GTx is launching a Phase IIIb trial of Acapodene in men undergoing androgen deprivation therapy for prostate cancer. Report

> The FDA has yet to complete a review of Advancis' marketing approval request for additional Keflex products. Keflex is a popular antibiotic. Release

And Finally… Researchers have found a genetic link for the hard-to-diagnose chronic fatigue syndrome. Article

SPOTLIGHT: Actavis bids $1.6 billion for Pliva

Thu, 16 Mar 2006 19:01:33 -0500

In a new sign of the ongoing consolidation of the global generic drug business, Iceland's Actavis has bid $1.6 billion to buy Pliva. If successful, a merger would create the third largest generic drug company in the world. Pliva shareholders will now have to consider a bid of $94.31 a share, a 34 percent premium of Pliva's three-month average. Release

DEALS: Caliper to buy Xenogen in $80M deal

Wed, 15 Feb 2006 19:01:32 -0500

Caliper to buy Xenogen in $80M deal

DEALS
WHO	WITH	WHAT	SCOOP
Caliper Life Sciences	Xenogen	$80M buyout	Xenogen makes cells, microorganisms and mice for research work.
GlaxoSmithKline	Pliva	$50 million R&D buyout	GSK acquires the R&D unit of Croatia's Pliva, which has specialized in developing antibiotics.
Pliva	Uso Racional	Acquisition	Pliva's buyout of Novartis' Spanish subsidiary fits into plan to focus on generics.
Genospectra	Panomics	Merger	Deal adds new operations for research reagents for transcription regulation, cell signaling and signal transduction.
Elan Corporation	Eisai	Acquisition of European rights to Prialt	The deal, for up to $100 million, nets Eisai the European market for the chronic pain therapy.
Akzo Nobel's Intervet	Bayer	Facility acquisition	Intervet adds a new vaccine production facility to its portfolio.
Cambrex Bio Science Walkersville	Cutanogen	Acquisition	The deal for $1.5 million in cash plus potential milestones adds business focused on treating severe burns.
Wulfing Holding	Myogen GmbH	Acquisition	Wulfing gains the European arm of Myogen and sublicenses heart failure therapy, Perfan IV.

GSK bags Croatian R&D unit in $50M deal

Mon, 13 Feb 2006 19:01:38 -0500

GlaxoSmithKline has agreed to pay up to $50 million for the research arm of Croatia's Pliva. Pliva gains $35 million up front and another $15 million in milestone paydays. GSK gains intellectual property and 135 staffers at the facility, which focuses on the development of new antibiotics. Pliva CEO Zeljko Covic says the deal allows his company to concentrate on developing its generics business. Pliva researchers are best known for developing the blockbuster antibiotic Zithromax. Recent attempts to duplicate that success, though, have fallen short. Analysts note that the deal marks GSK's interest in extending R&D efforts into a variety of areas.

- read this New Ratings report