Cannabis Derived Pharmaceuticals The Next Frontier?

Posted in BioBusiness

I wrote an article on the emerging medical marijuana and cannabis-derived pharmaceuticals market for Life Science Leader.

Please click here to view!

It was a very interesting article to research and fun to write Please let me know your thoughts and feedback!!!

 

Until next time….

Good Luck and Good Job Hunting (not when you are high of course)

Its Official: Biosimilar Monoclonal Antibodies Will be Legal in Europe

Posted in BioBusiness

The European Medicine Agency (EMA) recommended marketing authorization for two biosimilar versions of Johnson & Johnson’s Remicade, an anti-tumor necrosis factor (TNF) monoclonal antibody (MAbs) used to Crohn’s Disease, rheumatoid arthritis and other autoimmune diseases.  One of the MAbs named Remsima was developed by South Korea-based Celltrion and the other, Inflectra, was developed by US-based Hospira.   The European Commission is expected to follow the EMA committee’s advice and approve the products for a bunch of autoimmune diseases, including rheumatoid arthritis and Crohn’s disease.

According to a report by Fierce Biotech, Kim Hyoung Ki, senior vice president and chief financial officer at Celltrion, told reporters in Seoul today, that

“The price of Remsima will be more than 30 percent cheaper than those of the original drugs,”  We’re confident in Remsima as it has price competitiveness, while it has the same effect as the original drugs.”

Other biosimilar versions of MAbs including Rituxan, Herceptin, Enbrel and Humira are in various stages of clinical development.  Many of the branded MAb products represent the only treatment for certain types of cancer and autoimmune diseases and they are expensive to use.  Consequently, biosimilar manufacturers have them in their sights because the patents for many of these products are due to expire by 2018.

Although biosimilars are not yet legal in the US, it is simply a matter of time before they will become available to American patients.  The cost of healthcare continues to spiral upward and cost-savings of 25%-30% for many blockbuster biologics can help to better control those costs.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!

Sandoz Moves Its Biosimilar Development Strategy Forward

Posted in BioEducation

Sandoz, the generics division of Novartis, is currently the world leader in the biosimilar market. In fact, if it was not for Sandoz, the biosimilar industry may never have gotten started in the first place! As some of you may know, Sandoz sued FDA (and won) to gain approval of its biosimilar human growth hormone. While FDA contends that Omnitrope is not really a biosimilar (it was approved as a “drug” rather than a biologic) most analysts agree that it was the first biosimilar product ever approved and sold in the US. 

As part of its global biosimilar strategy, Sandoz today announced that it had initiated Phase III clinical trails for US approval of biosimilar version of recombinant human granulocyte-colony stimulating factor(G-CSF) or filgrastim (Amgen’s Neupogen®) and another for global launch of PEG-filgrastim (Amgen’s Neulasta®); a PEGylated form of G-CSF.

The filgrastim study is designed to evaluate the efficacy and safety of Sandoz’s biosimilar filgrastim versus Neupogen® in breast cancer patients eligible for myelosuppressive chemotherapy treatment. These trials expected to support extension of commercialization to the US, the largest global market for biologics. The pegfilgrastim study, which is being conducted in breast cancer patients undergoing myelosuppressive chemotherapy treatment, represents the next major step in the Sandoz global biosimilar development program. Previously, Sandoz announced that it had initiated late stage clinical trials for a biosimilar version of Roche’s monoclonal antibody cancer treatment Rituxan®). Finally, Sandoz has eight to ten different biosimilar molecules at various stages of development in its pipeline.

Sandoz currently markets and sells three biosimilars: filgrastim (Zario®), somatropin (Omnitrope®) and epoetin alfa (Binocrit®) in countries across Europe and elsewhere. As mentioned above Omnitrope is also sold in the US. However, because FDA has yet to craft a regulatory approval pathway for biosimilars (despite legislation mandating their approval) it is illegal to sell biosimilars (with the exception of Omnitrope) in the US.

Once vilified and staunchly opposed by most major pharmaceutical and biotechnology companies, the biosimilar business has been picking up steam in the past few years. To that end, companies like Merck, Pfizer, Teva and more recently Amgen and Biogen (all of whom lobbied against an approval pathway for biosimilars in the US) announced plans to compete on the global biosimilar market.

The decision of these companies to enter the biosimilar market is largely a result of downward pricing pressures on pharmaceutical and biotechnology drugs and near-empty drug pipelines at most major life sciences companies. Nevertheless, it is still not clear whether or not a robust biosimilar market truly exists. To wit, biosimilars have been in the market in the EU for the past fiver years and have not gained much traction there. However, the real biosimilar markets probably exist in China, Brazil and other emerging countries where there are large populations and emerging middle classes but drug prices are under tight government regulation. Because of this, the uptake of biosimilars in these markets will likely be greater than in Europe and the US.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!!!!!

 

In Case You Were Wondering: FDA Approved 35 New Prescription Medicines This Year

Posted in BioBusiness

Last week, the US Food and Drug Administration issued a press release lauding its approval of 35 new prescription medications in FY2001. According to the release 2011 was a banner year for drug approvals; being only surpassed in FY2009 when 37 new medicines garnered regulatory approval.

FDA detailed its accomplishments in a report entitled “FY2011, Innovative Drug Approvals” which touted faster approval times in the United States as compared with the FDA’s counterparts around the globe. Twenty-four of the 35 approvals occurred in the United States before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines. 

Among this year’s highlights:

  1. Two of the drugs – one for melanoma and one for lung cancer – are breakthroughs in personalized medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits;
  2. Seven of the new medicines provide major advances in cancer treatment;
  3. Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection;
  4. Ten are for rare or “orphan” diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema;
  5. Almost half (16) were approved under “priority review,” in which the FDA has a six month goal to complete its review for safety and effectiveness;
  6. Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so that the FDA could move the application through the review process without requesting major new information;
  7. Three were approved using “accelerated approval,” a program under which the FDA approves safe and effective medically important new drugs quickly, and relies on subsequent post-market studies to confirm clinical benefit. For example, Corifact, the first treatment approved for a rare blood clotting disorder, was approved under this program
  8. Thirty-four of 35 were approved on or before the review time targets agreed to with industry under The Prescription Drug User Fee Act  (PDUFA), including three cancer drugs that FDA approved in less than six months.

PDUFA was established by Congress in 1992 to ensure that the FDA had the necessary resources for the safe and timely review of new drugs and for increased drug safety efforts. The current legislative authority for PDUFA expires on Sept. 30, 2012. 

Maybe the agency can keep its streak alive before  PDUFA expires next year!

Until next time…

Good Luck and Good Job Hunting!!!!!

 

Biosimilar Regulatory Guidance is Imminent

Posted in BioBusiness

Late last week, Janet Woodcock, head of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation (CDER) made public comments which suggested that the long awaited guidance for approval of biosimilar products in the US was complete and likely to be issued by the end of this year. According to the Pharmalot Blog, another agency official suggested that the guidance may be “as early as the next few weeks, maybe even days.” Conventional wisdom suggests that the end of the year scenario may be more likely!

As widely anticipated, the guidance will resemble that already in place in Europe and will rely heavily upon analytical similarity of the biosimilar to the innovator product to determine the clinical testing requirement for approval of the molecule. Interestingly, Woodcock went out on a limb and suggested that the FDA approval process may make interchangeability feasible for biosimilars. For those who may not know, interchangeability or substitution allows pharmacists to substitute generic small molecules drugs for brand names when filling a prescription. This practice is legally allowed by the Hatch Waxman Act because FDA approval of a generic indicates that it biologically equivalent or identical to the branded molecule.

For those of you who have not close paid attention to the biosimilar brouhaha, a regulatory approval pathway for these molecules was implemented in Europe in 2004. Since that time, at least 10 biosimilar products have reached European markets. At present, biosimilars are still not legal in the US. While Woodcock and other FDA officials may be proud of their progress, why has it taken over 12 years for the agency to divine regulatory guidance for this class of molecules? 

Until next time…

Good Luck and Good Job Hunting!!!!!!

 

FDA Approves a First-Ever Scorpion Sting Treatment: Who Knew?

Posted in BioBusiness

While there is enormous unmet medical need out there, I never knew that the morbidity and mortality resulting from scorpion stings was so great. But, as the old adage goes; you learn something new everyday. To wit, the US Food and Drug administration earlier this week approved the first-ever treatment for scorpion stings.

According to a press release about the new product called Anascorp

 “Venomous scorpions (Centuroides) in the U.S. are mostly found in Arizona. Severe stings occur most frequently in infants and children, and can cause shortness of breath, fluid in the lungs, breathing problems, excess saliva, blurred vision, slurred speech, trouble swallowing, abnormal eye movements, muscle twitching, trouble walking, and other uncoordinated muscle movements. Untreated cases can be fatal.”

Anascorp, Centruroides (Scorpion) Immune F(ab’)2 (Equine) Injection, is made from the plasma of  horses immunized with scorpion venom. Anascorp may cause early or delayed allergic reactions in people sensitive to horse proteins.

FDA approval of Anascorp was based on results from a randomized, double-blind, placebo-controlled trial of 15 children with neurological signs of scorpion stings. The data showed that neurological symptoms resulting from scorpion stings resolved within four hours of treatment in the eight subjects who received Anascorp, but in only one of the seven participants who received the placebo. Of course, as is the case with ALL medications, the most common side effects were vomiting, fever, rash, nausea, itchiness, headache, runny nose, and muscle pain. In total, safety and efficacy data was collected from 1,534 patients in both open-label and blinded studies.

Anascorp was designated as an Orphan drug by FDA and received priority review. It is licensed to Rare Disease Therapeutics Inc., Franklin, TN, distributed by Accredo Health Group Inc., Memphis, TN, and manufactured by Instituto Bioclon, S.A. de C.V., of Tlalpan, Mexico, D.F.

Obviously, Anascorp is not likely to be a blockbuster product. But, if you are in the US Southwest and inadvertently are stung by an American scorpion you can rest assured that you will no longer have to worry about dying or suffering neurological damage. This news allows me to sleep better at night!

Until next time…

Good Luck and Be Careful Out There!!!!!!!

 

The Inside "Poop" On the Life Sciences Industry

Posted in BioBusiness

I attend this year’s BIO meeting in DC and ran into an old friend, Stan Yakatan of Katan Associates.  For those of you who do not know Stan, he has been associated in a variety of capacities within the Life Sciences industry for the past 35 years.

The job titles that he has accrued over his career include CEO, Chairman, Managing Director, Board Member, Investor, Entrepreneur and Mensch!  Hanging out with Stan at life sciences meetings is always interesting, exciting, unpredictable and most often fun!  That said, Stan is a wealth of information about the life sciences industry and I was surprised to learn that he has an invterview video on YouTube!

To that end, I thought it would be interesting to post the interview @BioJobBlog.  Stan’s historical and current perspective on the US life sciences industry is interesting to say the least!

 

 

If you want to contact Stan please click here!

Until next time…

Good Luck and Good Job Hunting!!!!!!!

Some Medical Devices Companies Jump on the FDA-Bashing Band Wagon

Posted in BioBusiness

Many life sciences company executives will tell you that getting US Food and Drug Administration (FDA) approval for their products has gotten tougher than it has been in the past 10 years or so. This shouldn’t come as a surprise to most BioJobBlog readers because there was almost know regulation of pharmaceutical, biotechnology and medical devices products during the eight years that Bush was in power. Seemingly, many life sciences companies have forgotten that FDA’s mission is to provide the American public with SAFE and efficacious drugs and devices; not to quickly approve products to bolster a company’s stock share price. That said, some medical devices companies, like their pharmaceutical and biotechnology cousins, have begun to complain about the FDA regulatory process for medical devices.

Historically, the regulatory challenges for getting medical devices approved have always been much lower than those for garnering approval of prescription drugs, vaccines and other biological products. Since 2000, the regulations guiding regulatory approval for medical devices had grown extremely lax.  For example, there has recently been a spate of recalls for certain previously-approved devices including cardiovascular stents, implantable cardiac devices and hip replacements.

The Obama administration is attempting to restore the rigor of the approval process and some medical devices companies are extremely unhappy about it. This renewed effort has forced some devices companies to eschew the lucrative US devices market entirely in favor of European and Asian markets; mainly because they were unable to garner FDA approval for their devices. Interestingly, the companies that are complaining the loudest are start ups rather than established medical devices companies. Their main complaints are the ever-increasing size of the clinical trials and length of time it takes to win regulatory approval for their products. Not surprisingly, these complaints are mostly driven by financial pressures at the start ups. Because of the recession, many of the venture capitalists who backed these companies have less money to invest and demand quicker and higher returns on their investments. Consequently, many of the star tups are under capitalized and simply don’t have the financial resources to stay in business and wait for FDA approval. While I understand their business pressures and urgency, winning FDA approval is suppose to be about safety and efficacy not about ROI. Maybe start up devices companies experiencing these difficulties ought to retool or reinvent their business plans!

To be clear, FDA approval rates for medical devices are down; 19 premarket approvals (PMA) were granted in 2010 as compared with 48 in 2000. Also, the average time to win 510(k) clearance (less stringent than PMA and used for most devices) rose to 116 days in 2008 from 97 days in 2002. There is no question that winning regulatory approval for new medical devices may seem to be getting tougher than in the recent past. But, if that helps to improve efficacy and patient safety than I don’t necessarily think that it is such a bad thing. And as Stephen Oesterle, MD senior vice president for medicine and technology at Medtronic (one of the world’s largest medical devices companies) aptly said in a recent NY Times article “The FDA is asking for larger trials, more thoughtful trials, all in the interest of the American public.”

Until next time…

Good Luck and Good Job Hunting!!!!

 

Abbott to Cut 1,900 Workers

Posted in BioJobBuzz

According to a post on the Pharmalot Blog, Abbott Laboratories today announced that it will eliminate 1,900 jobs or six percent of its workforce. The company cited its thinning pipeline and the current challenging regulatory environment for the corporate reorganization and downsizing. In other words, we are having trouble getting our new drugs approved and we can’t afford to continue to pay people’s salaries and benefits who aren’t delivering for us. The Pharmalot post didn’t provide specifics on the layoffs.  However, Lisa Madden a Delta  Pharma Recruiter and BioCrowd member  sent me a message and told me that 1,000 of the layed off workers were onsite employees and the remaining 900 were sales reps

Like it or not, this is the new reality for life sciences R&D types, So, if I were a  graduate student or postdoc considering a career in the life sciences industry, I highly recommend a well developed and carefully thought out “Plan B.”

Until next time,

Good Luck and Good Job Hunting!!!!!

 

BioJobs: So You Think You Want to Be a Regulatory Affairs Professional?

Posted in BioJobBuzz

Regulatory affairs professionals (RAP) are by far some of the most important employees at pharmaceutical, biotechnology and medical devices companies. Without RAPs, the requisite regulatory documents would not be filed and new drugs and devices would not be approved for marketing and sale.

Unlike other life sciences disciplines, a career in regulatory affairs is highly industry- specific and rarely taught at most academic institutions. In other words, if you are considering a career in regulatory affairs, don’t expect to get the training that you need in a PhD or postdoctoral training program; you will have to get it elsewhere!

A recent report compiled by the Regulatory Affairs Professionals Society (RAPS) entitled the “2010 Scope of Practice & Compensation Report for the Regulatory Profession” highlights the growing value and importance of regulatory affairs personnel in the life science industry. The report was compiled from the results of a survey of over 3000 regulatory affairs employees in 55 different countries.

The results show regulatory professionals are taking on a wider range of responsibilities, including becoming increasingly involved in critical business functions. Despite the economic downturn since the previous survey in 2008, overall compensation continued on an upward trend, although it grew at a slightly slower pace. The report also points to the continuing globalization of the profession, increased involvement with multiple product types and 6% higher compensation for professionals with Regulatory Affairs Certification (RAC).

Other important findings included in RAPS’ report include:

  • US respondents with the RAC credential reported average total compensation that was 6% higher than their peers without the RAC. Forty-four percent of all survey respondents are RAC certified.
  • The percentage of RACs is especially high in Canada (54%) and the US (47.2%). A little more than 21% of European-based respondents reported having the RAC.
  • Overall, about 34% of respondents said they were involved in comparative effectiveness research and reimbursement, up from 23% in 2008.
  • Half of all senior-level respondents reported being involved in government affairs.
  • About 70% of respondents said their work is either global in nature or focused on multiple regions of the world.
  • More than 68% reported involvement with multiple product types, a 6.3% increase from 2008.
  • Overall, just 5.7% reported working with biosimilars, a product category that was added to the survey for the first time, but 22% of respondents from Asia and Latin America reported involvement with biosimilars.
  • Nearly all respondents have a university degree; many have advanced degrees. The percentage of respondents whose highest degree earned is a master’s is up to 37.5%, a 17.2% increase from 2008. The percentage of respondents with MBAs and postgraduate certificates also increased.
  • Respondents reported significant professional experience outside regulatory, an indication that many have transitioned into regulatory from another, related field. Most have educational backgrounds in life sciences, clinical sciences or engineering.

If this sounds like a career option for you, I highly recommend that you visit the RAPS website. If you already have a PhD, masters’ degree or even a bachelor’s degree, getting RAC certification will certainly increase the likelihood of landing a regulatory affairs job in the life sciences industry. One caveat: the RAPS courses are not inexpensive and may require a substantial amount of time in order to pass the RAC examination.

If the RAC route doesn’t seem realistic or reasonable, try getting an entry-level job with the US Food and Drug Administration. Being an ex-agency employee will guarantee employment in the life sciences industry until you retire!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!