Author: Peter

An advisor to the pharma industry on M&A says the current boom in pharma valuations will not last, and R&D cost pressures will reshape firms of the future… transaction sizes of mergers and acquisitions in pharma have hit an all-time high: "You don’t see these revenue multiples in any other industry."…After the bubble bursts: what’s next for pharma?... in response to pressure from governments to lower their healthcare spending…R&D will become prohibitively expensive for medium-sized players, leading companies to reshape themselves according to four strategic archetypes:

1. Originators
2. Generics and biosimilar makers
3. Point-of-call specialists
4. Over-the-counter companies

..Imprimis says it will offer a compounded drug that includes Daraprim's active ingredient--pyrimethamine--in capsules starting at $99 for a 100-count bottle. The company is also starting a program to work with payers, pharmacy benefits managers and purchasing groups to offer patient-specific formulations "at prices that ensure accessibility."…The compounded drug isn't an exact copy; it also includes the ingredient leucovorin, which…helps to combat pyrimethamine's negative effects on bone marrow…After the meningitis outbreak linked to the New England Compounding Center, new regulations tightened up on distribution of compounded drugs, which aren't specifically approved by the FDA. Compounded meds can only be dispensed on specific prescriptions for specific patients, rather than distributed in bulk as FDA-approved products are...

Tricare officials say the problem stems from drug shortages…shortages are exacerbated within the military system because by law, DoD is allowed to buy pharmaceuticals only from certain manufacturers… shortages peaked at about the time DoD began requiring Medicare-eligible retirees and military family members to fill their long-term prescriptions by mail or at a military pharmacy…GAO Health Care Director Debra Draper pointed out that, since Tricare did not specifically track the satisfaction of beneficiaries now required to use the mail-order system and did not monitor the availability of covered medications for these beneficiaries, DoD is "unable to assess availability."…"DoD does not know what, if any problems, beneficiaries may have experienced filling their prescriptions,"…

..Duexis is a combination of two old drugs, the generic equivalents of Motrin and Pepcid…If prescribed separately, the two drugs together would cost no more than $20 or $40 a month. By contrast, Duexis, which contains both in a single pill, costs about $1,500 a month…Needless to say, many insurers do not want to pay for Duexis. Yet sales of the drug are growing rapidly, in large part because its manufacturer, Horizon Pharma, has figured out a way to circumvent efforts of insurers and pharmacists to switch patients to the generic components, or even to the over-the-counter versions…It is called "Prescriptions Made Easy." Instead of sending their patients to the drugstore with a prescription, doctors are urged by Horizon to submit prescriptions directly to a mail-order specialty pharmacy affiliated with the drug company. The pharmacy mails the drug to the patient and deals with the insurance companies, relieving the doctor of the reimbursement hassle that might otherwise discourage them from prescribing such an expensive drug...Horizon is not alone. Use of specialty pharmacies seems to have become a new way of trying to keep the health system paying for high-priced drugs.

Enforcement officers from the Medicines and Healthcare products Regulatory Agency have seized approximately half a million doses of unlicensed erectile dysfunction medicines, with an estimated value of more than £1 million ($1.5m), during a raid on in Datchet, Slough...A 37 year old man has been arrested… The news comes less than two months after Sundeep Amin from Essex was sentenced to 16 months in prison after MHRA officers seized £900,000 worth of falsified ED drugs en route from India..

…complaints might be dismissed as growing pains, born of resistance to change. But transitional chaos must be distinguished from enduring harm…the EHR's limitations and why they've been largely ignored, one key barrier is that physicians who voice reservations are labeled "technophobic, resistant, and uncooperative." But in fact…most physicians recognize the potential of EHRs and appreciate such features as the ability to view data remotely. Nevertheless, the researchers found remarkable EHR-induced distress. They conclude, "No other industry, to our knowledge, has been under a universal mandate to adopt a new technology before its effects are fully understood, and before the technology has reached a level of usability that is acceptable to its core users."...What this surgeon and the rest of us need are patient records that communicate meaning and foster understanding of the particular patient in question. The blanks on our screens can be filled with words, but the process of understanding cannot be auto-populated. Perhaps life without the EHR will soon be unimaginable. But the technology will support and improve medical care only if it evolves in ways that help, rather than hinder, us in synthesizing, analyzing, thinking critically, and telling the stories of our patients.

GNC Holdings Inc., the chain of health and wellness stores, plummeted as much as 21 percent after Oregon sued the company, claiming it sold supplements made with illegal ingredients…the company’s nutritional and dietary supplements were laced with unapproved drugs. One is picamilon, a Russian prescription medicine for neurological conditions, and the other is BMPEA, which was first synthesized in the 1930s as a replacement for amphetamines and never studied in humans, according to the state’s complaint.

Valeant Pharmaceuticals rout put specialty pharmacies under an unwelcome spotlight. But though Valeant's own close relationship with Philidor RX may be an unusual one--a host of Big Pharma and Big Biotech companies have now denied similar arrangements--tight links between drug marketing and specialty pharmacies are increasingly common industry wide…Valeant is hardly alone in depending on a specialty pharmacy for sales success. What began as a technique for getting "complex, costly drugs"--often orphan meds for rare diseases--to the appropriate patients has become a broadly used marketing technique…Pharma's pricing and marketing moves are going to stay on center stage for some time.

In their Perspective article…Avorn and Kesselheim argue that the 21st Century Cures Act, which is currently being debated in Congress, would lower the regulatory standards of the Food and Drug Administration by giving it greater discretion to approve drugs on the basis of less rigorous data…the legislation would authorize the FDA to "rely" on observational analyses, which are less rigorous than randomized controlled trials. But the Cures Act does not diminish the FDA's standards for requiring that new medical products are safe and effective. Rather, it recognizes that recent developments in genomics, systems biology, electronic data systems, and other fields can provide additional tools and resources to support better premarketing and postmarketing regulation and more efficient development of drugs and medical devices…Better evidence and up-to-date regulatory science are the best foundation for regulatory decisions and meaningful progress in biomedical innovation. They are also the best way to avoid turning back the clock on new opportunities to develop safe and effective treatments for unmet medical needs...

Food and Drug Administration recently approved…PCSK9 inhibitors…These novel biologic agents offer the promise of reductions in blood cholesterol levels. This broad indication sets the practice of cardiology on a collision course with specialty pharmaceutical pricing models…At its core, the current pricing model for these products is driven by a transformation in the pharmaceutical industry, whereby 84% of prescriptions are filled with generic products and follow-on biologics have the potential to disrupt many established markets and firms…for most firms, future revenue expectations hinge on novel therapies…without the potential for outsized returns, capital might not be available for early innovation in biotechnology. Pricing pressure on innovative products would drive a fundamental restructuring of the industry and further increase the financial challenges of bringing scientific innovations to the market. It is important that we manage these downside risks carefully as we work toward a more sustainable pricing model in this market.