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National Institutes of Health officials just wisely rejected a petition, supported by 51 congressmen, to exercise "march-in" rights to discourage drug "price-gouging." The proposal didn't merely violate the explicit intent of a decades-old statute — the Bayh-Dole Act — it also revealed the legislators' ignorance of drug development and would have devastated medical innovation, while doing nothing to bring down drug costs...The act allows the federal government to "march in" and seize the intellectual property rights of the inventor and grant a license to "a responsible applicant or applicants" under two highly unlikely conditions...First, if the patentee and its licensee have not taken effective steps to achieve "practical application" of the subject invention — in other words, if they're just sitting on it — the government can license the patent to someone who will develop it...The second condition is met when government action is necessary to alleviate health or safety needs that are not being satisfied by the rights holder...march-in rights would not necessarily lower drug prices. March-in rights do not empower the government to control prices — they only allow the NIH to increase competition by giving additional companies the right to utilize drug patents that were directly derived from the government-funded research...Encouraging the government to seize patent rights in a non-emergency situation is a great way to discourage firms from developing and producing any new drugs...

In an amazing display of bureaucratic hubris, the Centers for Medicare & Medicaid Services has proposed a mandatory, real-world experiment with provider reimbursement under the Medicare Part B program…CMS wants to reduce reimbursement for buy-and-bill drugs—but for only half of the country's providers. The other half will retain current reimbursement levels. After five years, CMS will see what happened…the proposal so overreaches that it will face enormous opposition and has little chance of being implemented…CMS’s proposed…Payment Model and the glaring methodological flaw that could end up raising drug costs…CMS wants to go after the buy-and-bill system’s theoretically…incentive for physicians to prescribe more-expensive drugs. For pricey specialty drugs, even a low single-digit markup over ASP can generate substantial dollar profits for a provider…These practices are for-profit private businesses. They will surely attempt to optimize against the CMS Phase I proposal by, for example, strategically directing patients to certain locations based on the cost of therapy and expected reimbursement…CMS even claims that its Phase I proposed model is “budget neutral.” This conclusion is based on the false assumption that there will be no behavior change in response to the study…CMS also ignores the possibility that patients will be shifted to higher-cost sites of care, including hospital outpatient departments…We are already seeing similarly brutal opposition to CMS’s latest brainstorm.

An influenza vaccine produced in tobacco plants could make a big impact in the market if it reaches the market in the US in time for the 2018-19 flu season, says a market analyst...The vaccine - currently being tested in phase III trials by Mitsubishi Tanabe - has clear advantages over not only vaccines produced via the traditional route in eggs but also newer vaccines produced in cell culture...Mitsubishi Tanabe's candidate is one of a number of flu vaccines in development based on the expression of virus-like particles - self-assembled units that are closer in structure to the wild-type virus than subunit-based vaccines made in eggs. Clinical trials suggest they may be able to provide greater and longer-lasting protective immunity...By incorporating influenza genetic material into tobacco leaves new vaccines can be made in as little as four weeks - six times faster than egg-based methods - which means producers can match circulating flu strains more closely. They can also react quickly if a new strain of the virus starts to emerge...plant-based manufacturing offers reduced infrastructure costs and can slash production times in half...If the company's product, or one like it, is approved, GlobalData expects a novel vaccine that boasts a rapid, plant-based manufacturing process to have a significant impact on the seasonal influenza vaccine landscape...

The charity Medicins Sans Frontieres has formally opposed U.S. firm Pfizer Inc's application for an Indian patent on a highly effective pneumonia vaccine, saying it could deprive many developing nations of cheaper copies of the drug...Some of the world's poorest countries and medical charities such as Medecins Sans Frontieres depend on India's robust pharmaceutical industry to make cheaper forms of drugs and vaccines developed by big Western pharmaceutical companies...If India granted Pfizer a patent on its Prevnar 13 pneumonia vaccine, Indian firms would not be able to produce affordable versions of it for domestic use or exports...To make sure children everywhere can be protected from deadly pneumonia, other companies need to enter the market to supply this vaccine for a much lower price than what Pfizer charges...

Based on the latest update to the Center for Drug Evaluation and Research’s Manual of Policies and Procedures, the Food and Drug Administration is looking to create more competition among generics — particularly for generics made by a single manufacturer... The updated MAPP outlines situations in which abbreviated new drug applications submitted by generics manufacturers will be eligible for an expedited review process, including submissions related to drug shortages, and legal requirements. Among them is the potential for expedited review for ANDAs related to what the agency calls "sole-source drugs" — drugs whose generic is manufactured by a single company...Submissions for drug products for which there is only approved product listed in the Prescription Drug Product List…of FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations...and for which there are no blocking patents or exclusivities may receive expedited review...

After years of enviable growth and brash moves, Valeant Pharmaceuticals appears to be succumbing to a broken business model...The beleaguered drug maker held a lengthy and much-anticipated briefing...for investors, and the news wasn’t pretty — the company cut its 2016 revenues and earnings forecast more than expected and disclosed weakness in areas of its business that caught investors by surprise. Particularly disturbing is the possibility that Valeant is in danger of defaulting on some of its debt...Valeant stock plunged 48 percent during the day on huge trading volume, continuing a slide that began last fall amid accusations by short sellers that the company had improperly booked revenue and used a specialty pharmacy to manipulate insurance reimbursements for key products. Even before the conference call ended, some Wall Street analysts recommended that investors flee.

...as of January only 240 to 290 prescriptions were being written per week. Sales are running at a rate of $11 million/year...Contrast these results with what occurred with the real Viagra. Launched...in 1998..had first-year sales of $788 million...1999, sales exceeded $1 billion and Viagra sales eventually progressed to over $2 billion annually...Is the HSDD (hypoactive sexual desire disorder) population grossly overestimated?..Addyi...is a flawed drug. Unlike Viagra, its effects are not immediate. A patient needs to take it every day for weeks before the effects kick in. Second, the drug is saddled with side effects such as dizziness, low blood pressure, fainting and sleepiness; plus, it’s contraindicated with alcohol consumption. Add all this to the issue of modest efficacy, and it could be that women don’t believe Addyi’s benefit is worth the risks…Perhaps sales will pick up with time...Advertising might also increase awareness, but Valeant agreed with the FDA’s request to delay direct-to-consumer advertising for 18 months. This moratorium, however, could end just in time for Super Bowl 52. One could only imagine the ad campaign that Valeant will employ, given their recent toenail fungus ads.

McKesson Corp. shares fell after the drug distributor said Wednesday night that it will fire 1,600 people, or about 4 percent of its U.S. workforce, to cut costs after losing some key customers...shares dropped 3.5 percent to $150.53...lost 32 percent in the past 12 months...The company began a strategic review...and determined that reductions to our workforce would be necessary to align our cost structure with our business needs...McKesson’s business has been hurt by the expiration of a contract with Optum...and changes in contracts with Omnicare Inc...and Target Corp...The company has been making acquisitions to boost growth. McKesson purchased Rexall Health, Canada’s No. 2 drugstore chain, for $2.23 billion in early March, and bought two oncology companies in February for $1.2 billion.

The Swiss importer that supplied fake Harvoni to Israel has named the Indian manufacturer from which it bought the drug and is cooperating with an investigation say regulators...The knockoff versions of Gilead's $1,350-a-pill hepatitis C drug seized by Israeli authorities were supplied by a Swiss trading firm, which sourced them from a manufacturer in India according to...Swissmedic...Under the Swiss Federal Act on Medicinal Products and Medical Devices, Swissmedic can neither name the Swiss trader nor contact any other customers to which it may have supplied Harvoni until the investigation is completed...Similar investigations have taken up to two years...Gilead licensed rights to manufacture and distribute pills...Harvoni...to...Indian companies Cadila Healthcare, Cipla, Hetero Labs, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab...

24/7 Wall St. has collected five big FDA decisions coming up in March and added some color, along with the trading range and price target.

1. Opko Health - FDA had accepted its New Drug Application for Rayaldee (calcifediol)...hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.
2. Acadia Pharmaceuticals - FDA will review data included in Acadia’s NDA for Nuplazid (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease
3. Radius Health - submission of the NDA...for the investigational drug Abaloparatide
4. BioMarin Pharmaceutical - pegvaliase for the treatment of phenylketonuria
5. Alder Biopharmaceuticals - chronic migraine study...evaluating quarterly self-injectable administration of ALD403