Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for dna.jpg[Update: The Workshop was cancelled on December 10, 2013, due to weather-related closure of the federal government. On December 30, 2013, FTC announced the Workshop would be held on February 4, 2014, at the FTC Conference Center at 601 New Jersey Avenue, NW, Washington, D.C. and will be webcast. FTC will publish an updated agenda and list of speakers. The comment period is unaffected by the rescheduling of the event, i.e., due by March 1, 2014.]

On December 10, 2013, the Federal Trade Commission (“FTC”) will host a Workshop on the Competitive Impacts of State Regulations and Naming Conventions Concerning Follow-on Biologics. FDA has yet to receive its first biosimilar application filed under the Biologics Price Competition and Innovation Act of 2010 (“BPCIA”). Despite this, the FTC believes that some state legislatures have already passed laws that may affect substitution of biosimilars for their referenced innovator biologic products. As a result, the FTC is concerned that these laws may deter the development of biosimilars and raise the costs for consumers without biosimilar options.

FTC’s Workshop plans to cover some of the following questions:

  • How would the new state follow-on biologic substitution laws passed this year, or similar proposals pending in other states, affect the competition expected between or among biosimilar, interchangeable and reference biologic medicines?
  • What are the rationales behind new state proposals and laws for regulating follow-on biologic substitution?

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Thumbnail image for Thumbnail image for Q1 ProductionisAddressing Industry Concerns Regarding FDA Regulation and Compliance While Improving Utilization of Clinical Outcome Assessments via Increased Instrument Efficiency and Use of Innovative Technologies to Ensure FDA Label Inclusion
Clinical outcome assessments within the pharmaceutical industry provide critical data to researchers to support a variety of claims, from safety to cost effectiveness, to regulatory bodies as well as healthcare providers and third-party payers. Pharmaceutical executives are eager to maximize the use of outcome assessments, but must understand the optimal tools that will enable them to effectively collect, validate, and analyze the information gathered from patients, clinicians and proxy caregivers.

The Maximizing Patient, Observer & Clinical Reported Outcomes Conference will provide an opportunity for executives throughout the industry for high-level education and networking, blending perspectives from academia, industry-veterans, and regulatory authorities. This event will take place in Alexandria, VA on January 13-14, 2014. Sessions will cover a range of topics, including presentations highlighting various instruments that can be utilized to collect reported outcomes, as well as new applications and mobile technologies, modernizing the methods through which this information is gathered. Insightful commentary will also provide detail on validation methods, as well as techniques for working with the range of observers and with the most appropriate tools for those populations.
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genericdrug.jpgFDA is proposing to amend its regulations to permit generic drug companies to add or strengthen safety warnings in labeling of their products on the basis of newly acquired safety information, even before the Agency has approved this safety information in the labeling of corresponding brand name drugs.

Under current rules, a generic drug must have the “same labeling” as its reference listed drug. This prevented an ANDA holder from inserting or altering a safety communication unless and until FDA has approved this information in the labeling of the brand name drug.

The purpose of the amendment is to “level the playing” field for generics, which arises from two conflicting Supreme Court decisions involving Federal preemption of safety warnings in prescription drug labeling. In Wyeth v. Levine, the Court held that a failure to warn claim in a Vermont personal injury action was not preempted by FDA labeling regulations, because the brand name drug company could have voluntarily amended its labeling to include a stronger safety warning even if FDA had not approved it. In contrast, the Court subsequently held in Pliva v. Mensing that a state failure to warn claim was preempted by FDA-approved labeling, since the generic company could not unilaterally add or strengthen its warning due to the same labeling requirement.
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troll.jpgOnce again, legislation aimed at deterring abusive patent litigation is making headlines. The Patent Litigation Integrity Act of 2013 (S. 1612) was introduced by Senator Orrin Hatch, R-Utah, on October 30, 2013, and seeks to address patent troll litigation abuses by targeting “the economic incentives that fuel frivolous lawsuits.”

Patent troll litigation is often characterized by non-practicing entities, holding patents in a shell company with very few assets, who bring baseless claims, and seek nuisance settlements. The Bill seeks to address those concerning aspects of patent troll litigation in two ways: (1) by awarding fees to the prevailing party and (2) by requiring patent trolls to post a bond sufficient to cover the accused infringer’s fees.

Fees would no longer just be awarded to the prevailing party in exceptional cases at the court’s discretion. In the proposed Bill, the court would be required to award fees to the prevailing party, except if the court found that the nonprevailing party’s position was substantially justified or the award would be unjust. With this deterrent, the Bill hopes that patent trolls will think twice about bringing baseless claims and that defendants, knowing they will be awarded their fees if they prevail, won’t be as quick to take a nuisance settlement.
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Thelymphaticsystem_2011_large.jpgOn November 13, 2013, FDA approved Imbruvica® (ibrutinib) for the treatment of patients with mantle cell lymphoma (“MCL”), a rare and aggressive form of non-Hodgkin lymphoma or blood cancer. Imbruvica® will be co-marketed by Pharmacyclics, Inc. (“Pharmacyclics”) based in Sunnyvale, Calif. and Janssen Biotech, Inc. (“Janssen”) based in Raritan, N.J and will be sold as a single agent oral capsule.

Imbruvica® has been approved for patients with MCL who have received at least one prior therapy and works by blocking a specific protein called Bruton’s tyrosine kinase (“BTK”). Non-clinical studies have shown that blocking BTK inhibits malignant B-cell survival. The recommended dose of Imbruvica® is 560 mg (four 140 mg capsules) once daily. About six percent of all non-Hodgkin lymphoma cases in the U.S. are classified as MCL. MCL is often diagnosed in an advanced stage after it has already spread to the lymph nodes, bone marrow and other organs.

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Written by Shelly Fujikawa. Ph.D

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Imbruvica® was approved as part of the Breakthrough Therapy Designation (“BTD”) program that facilitated its development, review, and approval. Imbruvica® was granted three BTDs by FDA, including relapsed or refractory MCL, and is the second drug with a BTD to receive FDA approval.
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dna.jpgYears have passed since enactment of the Biologics Price Competition and Innovation Act of 2009 (“BCPIA“), and we have been waiting for developments–from government, industry, and/or law–that would spark life into the biosimilars’ industry. But, with FDA taking a wait-and-see approach, industry unwilling to act without more FDA guidance, and the courts not having any cases to decide, progress on the biosimilars’ front has been slow.

Some of that may change though after a judicial decision coming out of the Northern District of California this week. There, Judge Maxine Chesney nixed Sandoz’s early challenge to two Hoffman-La Roche (“Roche”) patents covering etanercept, a human tumor necrosis factor receptor. Amgen, the exclusive licensee of the patents, claims they cover its Enbrel® product. Sandoz, who is currently conducting clinical trials to test an etanercept product, stated that once the trials were complete, it intended to file an application for licensure of its etanercept product as biosimilar to Enbrel®. Accordingly, Sandoz sought a declaration that its claimed biosimilar product did not infringe either patent, and that both patents were invalid and unenforceable.

Sandoz contended that declaratory relief was appropriate, because it had provided notice of commercial marketing. In opposition, Roche and Amgen made two related arguments: (1) the district court did not have standing to consider the patent dispute, because Sandoz had not yet submitted an application to FDA and (2) there was no cognizable case or controversy. The court agreed with Roche and Amgen, finding a number of problems with Sandoz’s position.
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[Update: After unanimously passing the Senate on November 18, 2013, H.R. 3204–the Drug Quality and Security Act–is set to become law after an expected signature from President Obama. President Obama signed into law on November 27, 2013.]

On November 12, 2013, the Senate voted to close debate on and advance a compounding pharmacy bill–H.R. 3204–aimed at tightening government oversight of pharmacy compounding and creating a national tracking system for prescription drugs. The 97-1 vote indicated overwhelming bipartisan support for the proposal, which passed the House in September. The lone dissenter, Sen. David Vitter, objected to a final Senate vote on the proposal because he wanted the Senate to first vote on a measure that he proposed to require lawmakers to disclose which of their aides are signing up for health insurance under the Affordable Care Act and which are remaining in the Federal Employee Benefit Program.

Originally introduced in the House by Rep. Fred Upton, H.R. 3204–the Drug Quality and Security Act–seeks to address two major concerns regarding the safety and quality of the U.S. drug supply. First, and in response to last year’s deadly meningitis outbreak, the Bill seeks to strengthen government oversight of compounding pharmacies. More specifically, Title I–the Compounding Quality Act–would amend the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) as to the regulation of compounding pharmacies, which have historically been regulated by state pharmacy boards. Under the proposal, pharmacies that perform traditional, small-scale compounding will continue to be regulated by state pharmacy boards. Additionally, drugs compounded by or under the direct supervision of a licensed pharmacist in a facility can elect to register as an outsourcing facility. In doing so, these drugs would be exempt from the FD&C Act’s labeling, new-drug, and proposed track-and-trace requirements if certain conditions were met, including: (1) proper registration of the facility; (2) no compounding using bulk drug substances; (3) compounding with ingredients that comply with applicable standards; (4) no compounding of drugs that have been withdrawn or removed due to lack of safety or efficacy; (5) no compounding of drugs that are essentially a copy of one or more approved drugs; (6) no compounding of drugs that have been identified as ones that present demonstrable difficulties for compounding; (7) no sale or transfer of the compounded drug by any entity other than the outsourcing facility; and (8) appropriate labeling.

The Bill also seeks to increase protection of the prescription-drug supply chain. More specifically, Title II–the Drug Supply Chain Security Act–will establish requirements to establish a track-and-trace system that will follow prescription drugs from manufactures to retail pharmacies. This national system should facilitate greater protection against counterfeiting, earlier detection of possible drug shortages, simpler recalls of defective drugs, and other drug supply-chain issues. While there will be certain waivers and exemptions, the proposal would require drugmakers to affix a product identifier on each package and case of product intended to be introduced in a transaction into commerce. Ten years after enactment, the Bill adds an electronic-tracing requirement. The Bill will require FDA to publish guidelines: (1) establishing standards for the interoperable exchange of transaction information, transaction history, and transaction statements; and (2) establishing the process by which companies may obtain waivers, exceptions, and/or exemptions to the product-identifier requirements. The national track-and-trace program will also preempt all state and local requirements regarding tracing drugs through the supply channels.
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epilepsy.jpgOn November 8, 2013, FDA approved Aptiom® (eslicarbazepine acetate), manufactured by Sunovion Pharmaceuticals (“Sunovion”), as a once-daily, immediate-release, adjunctive therapy for partial-onset seizures associated with epilepsy in adults 18 years or older. Partial or localized seizures affect only part of the brain at onset and are the most common type of seizure in epilepsy patients. Seizures can cause a wide range of symptoms, including repetitive limb movements, unusual behavior, and generalized convulsions with loss of consciousness and can have serious consequences, including injury and death. Epilepsy is one of the most common neurological disorders affecting nearly 2.2 million people in the U.S.

Aptiom® is an oral drug that stabilizes the inactive state of voltage-gated sodium channels and blocks T-type voltage-gated calcium channels. Sunovion recommends treatment using 400 mg once daily initially for one week followed by a dosage increase to a recommended maintenance dosage of 800 mg once daily. The maximum recommended maintenance dosage is 1,200 mg once daily. FDA noted that existing treatments do not achieve satisfactory seizure control from existing treatments. Sunovion, the U.S.-based unit of the Japanese drug maker Dainippon Sumitomo Pharma Co., expects Aptiom® to be available in U.S. pharmacies in the second quarter of 2014. FDA did not classify Aptiom® as a controlled substance.

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Written by Shelly Fujikawa. Ph.D

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Sunivion submitted Aptiom® for approval based on three, large phase 3 randomized, double-blind, placebo-controlled, safety and efficacy trials that included more than 1,400 patients with partial-onset seizures inadequately controlled by one to three concomitant, antiepileptic drugs, including carbamazepine, lamotrigine, valproic acid, and levetiracetam. These trials, jointly performed with BIAL-Portela & Ca, S.A. (“BIAL”), demonstrated a statistically-significant reduction in standardized seizure frequency compared to placebo. Significantly more treated patients had a seizure frequency reduction of 50% or more from baseline (41% compared to 22%).
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transfat.jpgFDA has tentatively found that partially hydrogenated oils (“PHOs”), the primary dietary source of trans fatty acids, are no longer generally regarded as safe (“GRAS”). While PHOs are used in a number of food products (e.g. margarine, shortening, and baked goods), they have been linked to significant health risks, such as coronary heart disease. FDA’s tentative determination that PHOs are no longer GRAS means that PHOs would now be classified as “food additives,” subject to Section 409 of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) (21 U.S.C. 348). FDA does not allow food manufacturers to sell food additives, directly or indirectly, without prior approval for us by FDA.

The FD&C Act defines a “food additive” as “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food….” 21 U.S.C. 321(s). Except that GRAS substances are not considered food additives. A substance is GRAS if it is generally recognized to be safe under the conditions of its proposed use “among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures.” In addition, if the substance had been used in food before January 1, 1958, it could be considered GRAS based on experience form its “common use” in food. However, even common use in food cannot overcome new evidence demonstrating that a consensus no longer exists that the substance is safe.

While some GRAS substances are listed in the regulations, there is no comprehensive list of GRAS substances. With the passage of the Food Additives Amendment to the FD&C Act in 1958, FDA established a list of GRAS substances. And in 1972, FDA instituted a notice-and-rulemaking procedure for affirming certain substances as GRAS. However, in 1997, FDA instituted a voluntary notification program for GRAS substances, which does not require notice-and-comment rulemaking. Thus, in many cases, food manufacturers and users have been responsible for determining whether substances are GRAS in light of the views of experts. For example, partially hydrogenated soybean oil and partially hydrogenated cottonseed oil were considered GRAS based on common use prior to 1958, but are not listed as GRAS in any FDA regulation.
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Korea-MD, USA Bio Expo Opening Ceremonies.JPGOn November 7 and 8, 2013, FLH attorneys Brian J. Malkin, Charlie J. Raubicheck, and Scot B. Pittman attended and participated as sponsors of the 3rd Annual Korea-Maryland, USA Bio Expo. The Expo hosted leading Korean pharmaceutical, biotechnology, and medical device companies at the Universities at Shady Grove Conference Center in Rockville, Maryland. The event provided networking opportunities and seminars from industry professionals with the goal to encourage collaboration of Korean biotechnology businesses utilizing the resources in the Washington, D.C. area.

The opening ceremonies featured presentations by a variety of local and Korean representatives committed to helping Korean business set up operations in the United States, particularly Maryland, and specifically Montgomery County. The speakers included:

  1. Ambassador for Green Growth & Environment, Kyungryul An
  2. Embassy of the Republic of Korea, Consul-General Do-ho Kang
  3. Maryland Secretary of State, John P. McDonough
  4. BioMaryland Center Executive, Director Judy Britz
  5. Montgomery County Executive, Isiah Leggett
  6. Montgomery County Department of Economic Development Director, Steve Silverman
  7. Hanbat National University Graduate School, Dean Byung Wook Ahn
  8. George Washington University, Department Chair of East Asian Languages and Literatures Young-Key Kim-Renaud.

The Maryland representatives highlighted some of the advantages for doing business in Maryland. For example, Maryland offers income tax credits equal to 50% of an eligible investment for investors in Qualified Maryland Biotechnology Companies (“QMBCs”). This tax credit program offers incentives for investment in seed and early stage, biotech companies, up to $250,000. To qualify, companies are required to: be less than 15 years old; have their headquarters and base of operations in Maryland; employ fewer than 50 people, and have a valid certification from the Department of Business and Economic Development (“DBED”). Investors are required to submit applications prior to making an investment. DBED reviews the applications and issues initial credit certifications within 30 calendar days.( ). Chevy Chase, Maryland also is home to a branch of NEA, one of the country’s largest venture capital funds, with the potential to help support Maryland businesses such as those in the biotechnology field.
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