Pfizer scouts for bite-sized buyouts after Lipitor sales wilt

Posted under Blog, Companies, Diagnostics, Funding, Ian Read, Lipitor, M&A, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Startups, Universities, Videos by rmcbride

Pfizer ($PFE) CEO Ian Read (photo) has been on the lookout for M&A deals that could bring the U.S. pharma giant new treatments for cancer, diabetes and neurological disorders amid plunging sales of the company's blockbuster heart drug Lipitor. And he tells Reuters that he's looking for buyouts with price tags of roughly $4 billion to do the job.

Followers of Pfizer won't be surprised to learn of Read's M&A appetite, yet the pharma chief happens to be scouting for deals at an interesting time in the industry and at his company. Last week, Pfizer announced the sale of the company's baby formula unit for $12 billion, as Reuters notes, providing the company with resources to focus on its core pharma business. At the same time, mid-sized drug companies such as Human Genome Sciences ($HGSI), Amylin Pharmaceuticals ($AMLN) and Warner Chilcott ($WCRX) are up for sale.

Yesterday, of course, the reality of generic competition for Lipitor reverberated after Pfizer reported that U.S. Lipitor sales shrank 71% in the first quarter. The decline of the megablockbuster franchise pressures executives to find new products to replace revenue from the falling Lipitor sales. However, Read isn't interested in filling the hole with another megadeal on par with the $67 billion merger with Wyeth a few years ago.

A "bolt-on" deal akin to Pfizer's $3.6 billion buyout of pain med specialist King Pharmaceuticals suits the company's needs, Read told Reuters. "That's not a hard number--around that [amount] or a multiple of that if it was an attractive asset."

These are good times for companies with attractive assets such as Amylin, which recently won approval for the long-lasting diabetes drug Bydureon. Gilead's ($GILD) buyout of Pharmasset for nearly $11 billion, and Bristol-Myers Squibb's ($BMY) recent offer to acquire Amylin for $3.5 billion, show that buyers are willing to shell out premiums for worthy drug developers.

The upshot: Pfizer will likely have serious competition for the size and types of deals Read wants to make.   

- check out Reuters' analysis
- and news of Warner Chilcott's desire to be sold

Special Report: Ian Read - The 25 most influential people in biopharma today

Related Articles:
Shrinking Pfizer targeting new round of small, tailor-made buyouts and pacts
Pharma rides a wave of targeted M&A deals
Pfizer targets miniblockbuster prospects as Lipitor patent expires

Abbott tries to throw up roadblock to Humira biosim

Posted under Abbott Laboratories, biosimilars, Blog, Companies, Diagnostics, Funding, Humira, Lipitor, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Startups, Universities, Videos by john

While Pfizer ($PFE) was reporting a 71% drop in U.S. Lipitor sales and plotting its next spinoff move, Abbott Laboratories ($ABT) was working to shore up its own breakup plans by protecting its pharma unit's lead drug. The Chicago-based company petitioned the FDA to stop biosimilar versions of Humira, its lead drug, on trade-secret grounds. Report

Pfizer turns to late-stage pipeline to make up for Lipitor crash

Posted under Alzheimer's, Alzheimer's disease, bapineuzumab, Blog, Companies, Diagnostics, Eliquis, Funding, Lipitor, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Startups, tofacitinib, Universities, Videos by john

As expected, Lipitor sales are being blasted by generic competition in the U.S. And with Pfizer's ($PFE) sales numbers plunging, the pharma giant is staying focused on the fate of a trio of late-stage therapies that are desperately needed to fill a growing gap.

For the record, Lipitor sales in the U.S. dropped 71% in the first quarter. But Pfizer is betting that after years of pipeline snafus and bad deal-making strategies, it can demonstrate once and for all that it has turned the corner on a smarter, more focused development approach.

The three main characters in that story line are tofacitinib, a potential blockbuster for rheumatoid arthritis with an August PDUFA date, the anti-clotting drug Eliquis, up for a decision in June, and the high-risk Alzheimer's Phase III studies for bapineuzumab.

Some analysts have been fretting over safety issues for tofacitinib, as Dow Jones' Peter Loftus reports. But many still expect it to fare well at the FDA, which is an experienced hand at considering the risk/benefits of new RA treatments. Eliquis, meanwhile, is widely considered an odds-on favorite for an approval. The wild card is bapineuzumab, partnered with Johnson & Johnson. According to Dow Jones, Pfizer expects late-stage data in the summer. But TheStreet's Adam Feuerstein tweeted this morning that the first Phase III trial is finished but Pfizer wants to wait until the second study is completed later in the year before releasing data. 

For Feuerstein, one of many Alzheimer's skeptics who have seen a series of R&D fiascos in the space, that's an ominous sign. A number of analysts note that an approval would be worth billions, but the odds of success are slim. A pair of regulatory wins ahead of the data release, though, would soften any blow from a bapi failure.

- here's the story from Dow Jones

Related Articles:
Pfizer faces bumps in road with potential blockbuster RA pill
Pfizer R&D chief talks up chances for late-stage Alzheimer's drug
Pfizer, Lilly earnings drop on new generic rivals

Sanofi, Regeneron report stellar LDL drug data as race heats up

Posted under Amgen, Blog, cholesterol, Companies, Diagnostics, Funding, Lipitor, Medical Devices, Medical Supply, Pharmaceuticals, Regeneron Pharmaceuticals, Sanofi, Startups, Universities, Videos by John Carroll

With an eye to keeping its lead on Amgen ($AMGN), Sanofi ($SNY) and Regeneron ($REGN) today noted that their rival PCSK9 inhibitor triggered a significant drop in LDL levels among patients with a high level of the "bad" kind of cholesterol. Responding to the promising Phase II data, Sanofi R&D chief Elias Zerhouni vowed to pivot into a late-stage program in the second quarter.

The key numbers for Sanofi were recorded in two groups among the 183 patients recruited for the study. In one group patients taking SAR236553/REGN727 in a subcutaneous injection twice a month registered a 72% mean drop in LDL compared to a 5% drop in the placebo arm. A separate cohort taking the twice-monthly treatment along with 80 mg of Lipitor saw a 73% reduction compared to an 18% drop for the Lipitor-only arm.

"I've not seen anything like this in all my days of research," says James McKenney, CEO of National Clinical Research and the lead investigator, who has been studying drugs for three decades. "This is so impressive."

The mid-stage data reflected an improvement over early-phase results, adds McKenney. In an interview with FierceBiotech he added that the longer you give the drug to a patient, the more efficacious it becomes. And one of the central objectives of this study was to zero in on the best dosage and frequency of treatment. 

"No one else has finished the Phase II," he added. "We're the first ones out."

"There are a lot of implications for people who receive gold standard statins and either don't respond in a way that gives them a vigorous reduction or can't tolerate high doses, experiencing muscle pain and weakness," added McKenny. "That's the group that is an obvious low-hanging fruit that needs additional help. And this product based on what we found can give them a remarkable and dramatic additional lowering" of LDL. Later, he added, investigators will be able to assess the potential health benefits for the broader population.

Just how big that market might be triggered some chatter on Twitter over the weekend, with at least one analyst raising concerns that only a small subpopulation of patients could benefit from LDL drugs like the ones Amgen and Sanofi/Regeneron are investigating. But in a recent note, Jefferies analyst Biren Amin reportedly noted estimates that 77 million U.S. adults have high levels of LDL, with an estimated 3.4 million high-risk patients that could benefit most from a treatment like this.

According to their release, serious adverse events occurred in one patient receiving placebo and three patients in the active treatment arms, including a patient on active treatment who experienced a skin rash diagnosed as leukocytoclastic vasculitis.

"Based on this finding and the results of our Phase II trials, Sanofi and Regeneron plan to initiate the SAR236553/REGN727 Phase III program in the second quarter," says Zerhouni.

- here's the press release

Related Articles:
Amgen's LDL blockbuster hopeful wows with impressive efficacy data
Sanofi touts R&D hopefuls as tonic for plunging profits
Developers spotlight huge potential of new class of cholesterol drugs