Medidata Solutions is a leading provider of clinical trial solutions that enable the world’s most advanced life science organizations to maximize the value of their clinical research investments by putting powerful tools into researchers’ hands. A pioneer since 1999 in innovative technologies for planning and managing clinical studies — including protocol design; clinical data capture, management and reporting; and trial contracting and negotiation — Medidata Solutions and its global network of business partners address the unique needs of sponsors and sites of all sizes. With deep expertise in conducting studies across all phases and therapeutic areas, on six continents and in more than 80 countries, Medidata Solutions helps clinical researchers reduce trial cycle times, achieve early visibility to reliable clinical data, and maintain strict fiscal responsibility, while safely accelerating the process of bringing life-enhancing treatments to market. Link
GE Healthcare will establish a new US headquarters for its life sciences division in Massachusetts, in a move that could bring hundreds of jobs to the state. The company declined to provide details, including where the headquarters will be located in Massachusetts. The unit is based in Piscataway, N.J., where it employs about 400 people. It is unclear how many of those jobs will come to Massachusetts, but GE issued a notice to New Jersey government officials that 218 positions in Piscataway will be affected by the move, beginning Jan. 1. Link
2) FDA approves J&J diabetes drug Invokamet – Pharma Times – 8/10/14
The US Food and Drug Administration has approved Invokamet, a fixed-dose therapy combining Invokana (canagliflozin) and metformin. Link
3) Accepting the challenge: Here’s how close we are to a new drug for ALS – Boston Business Journal – 8/12/14
So you’re standing there, dripping wet, having just dumped a bucket of ice water over your head in the name of ALS. The thought occurs to you to ask: What exactly am I doing this for? What you probably don’t know is that while there’s only one late-stage trial in the world being conducted of a drug intended to address the root causes of ALS, local companies from Biogen Idec to the Third Rock-back startup, Voyager, are also working on drugs in much earlier stages of development. Link
4) Seventh Sense raises $16 million for blood collection device – Beta Boston – 8/13/14
Cambridge’s Seventh Sense Biosystems has closed a Series B round of $16 million to complete the development of its more convenient and efficient blood collection system. Link
5) UniQure bets on a gene therapy for heart failure – Fierce Biotech – 8/11/14
After making international headlines with the West’s first approval for a gene therapy, pioneering biotech uniQure is working to flesh out its pipeline of one-time treatments, buying into an early-stage shot at heart failure that could put its technology on the biggest stage yet. Link
The BioPharm America 2014 Program Overview is now available online!
MassBio members save $200 on registration! Be sure to mention MassBio in the registration comments field!
BioPharm America is where biotech industry partnerships get started. Meet face-to-face with biotech and pharma executives from around the world to identify and enter strategic relationships. Equipped with partneringONE®, the world’s leading web-based partnering system for the life science industry, BioPharm America is the only event in North America based on the same reputable formula as EBD Group’s acclaimed European events BIO-Europe® and BIO-Europe Spring®.
Keynote speakers include:
Flemming Ornskov, CEO of Shire
Gary Nabel, CSO of Sanofi
Sessions will cover:
- The Perfect Pitch: Do you Have What it Takes to Win Over Investors?
- How Unconventional Pharma & VC Collaborations are Expanding R&D Budgets
- The Pressures of Being an Early Stage Public Company
- Clinical Outlook for New Immuno-Oncology Treatments
- Key Partnerships in Advanced Therapies: Pharma May Have Company
- The Power of the Patients: How Patients are Getting Things Done in the Drug Development Process
- And more!
BioPharm America™ 2013 Highlights
- 900+ attendees
- 2,950 one-to-one meetings
- 757 licensing opportunities posted
- 550 companies
- 75 company presentations
- 15 exhibitors
- 35 countries represented
- 20 workshops and panels
FDA Issues Draft Guidance on Regulatory Exclusivity for Biologics – Guest Post by Konstantin Linnik, Ph.D
By Konstantin Linnik, Ph.D.
On August 4, 2014, the US Food and Drug Administration released Draft Guidance on determining eligibility of a biological drug for regulatory exclusivity.
Under the Public Health Service Act (PHS Act), as amended in 2010, an abbreviated biosimilar application can be accepted by the FDA, but not until 4 years after the first licensure of the original reference product and, once accepted, such an application cannot be fully approved by the FDA for a period of 12 years from the reference’s first licensure. This reference product exclusivity is granted independently of any patent exclusivity, and therefore, by itself, provides a significant incentive to the sponsor of a Biologic License Application (BLA) who obtains the first licensure status. The date of first licensure is also critical to the timing of a follow-on biosimilar entry to the market.
Sponsors of the original BLAs generally have superior information about their products, and therefore, could gain an unfair advantage from evergreening BLAs based upon minor product improvements, each with 12 years of additional exclusivity. However, not every BLA triggers an exclusivity period. Specifically, under section 351(k)(7)(C) of the PHS Act, a new period of exclusivity is not available to the same sponsor or an affiliated party if the same product is licensed for a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength. Additionally, a structurally modified product is not eligible for a new period of exclusivity if such structural modification does not result in improved safety, purity, or potency.
The Draft Guidance provides the agency’s interpretation of the following key provisions in Section 351(k)(7)(C):
- who is considered an affiliated entity (as in “licensor, predecessor in interest, or other related entity”);
- what is meant by “modification to the structure”;
- how BLA applicants can demonstrate to the FDA that a structural change indeed results in “a change in safety, purity, or potency.”
The Draft Guidance will be of particular interest to BLA sponsors who are aiming at extending market exclusivity by developing second generation, improved biologics, also known as “biobetters.” Additionally, the Draft Guidance may impact BLA sponsors who have multiple related products in development, for example, multiple antibodies against the same target. In many situations, the availability of regulatory exclusivity, or lack thereof, will have an impact on patent strategy and, ultimately, on the valuation of a drug or drug candidate.
All comments on the Draft Guidance should be submitted to the FDA within 60 days from publication in the Federal Register, i.e., by October 6, 2014.
This post was written by Konstantin Linnik, Ph.D., a partner in the Boston office of Nutter McClennen & Fish LLP, and co-chair of MassBio’s Legal & Regulatory Working Group. This post is for informational purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising.
Guest Posting Disclaimer: Guest Postings on the MassBioHQ blog are submitted by individual guest posters and in no way represent the opinions or endorsement of MassBio or MassBio employees. MassBio does not represent or guarantee the truthfulness, accuracy, or reliability of statements or facts posted under the Guest Postings on the MassBioHQ blog.
DV Biologics is a global supplier of human biological tools to academic institutions and pharmaceutical companies engaging in cell and drug based discovery and development. Our mission is to provide biological tools needed to advance the innovation of technology that will ultimately be used to treat or prevent multiple human degenerative disorders and diseases. DV Biologics offers a diverse range of novel human biological tools and services that can be used to study various human pathological conditions in addition to an expanded product portfolio of unique cell types and tissue-derived products. Link
Nanobiotix is a clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer. The Company’s first-in-class, proprietary technology, NanoXray, enhances radiotherapy energy with a view to provide a new, more efficient treatment for cancer patients. NanoXray products are compatible with current radiotherapy treatments and are meant to treat a wide variety of cancers (Soft Tissue Sarcoma, Breast Cancer, Liver Cancer, H&N cancer, Glioblastoma, Prostate…) via multiple routes of administration. Nanobiotix’s lead product NBTXR3, based on NanoXray, is currently under clinical development for soft tissue sarcoma and locally advanced head and neck cancer. The Company, based in Paris, France, has partnered with PharmaEngine for clinical development and commercialization of NBTXR3 in Asia. Link
Siamab Therapeutics is a biopharmaceutical company developing novel cancer immunotherapies. Siamab has developed a platform of technologies that enable the rapid discovery and development of therapeutic antibodies that bind to a novel class of carbohydrate antigens present on cancer cells. The company’s lead program is in preclinical studies for the treatment of solid tumors. Link
Thrive Bioscience™ is an early-stage life science analytical and automation technology company based in the Boston, Massachusetts, USA area. Founders and leadership of the company are an experienced team composed of industry leaders with successful track records for developing new lab instrumentation from concept through commercialization. They have managed numerous successful exits, including trade sales and IPO’s. They are building a global investor and strategic partner and customer base, and plan to manufacture components in multiple locations worldwide, including the Americas, Europe, and Asia. Link