Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

SERONO SUPPORTING CASE-BY-CASE RECONSIDERATION OF EXCLUSIVITY benefits under the Orphan Drug Act as a means of correcting "rapacious misuse" of the law. In a position paper developed during the week of Oct. 2, the company maintained that Congress should adopt an amendment to the act to allow the withdrawal of market exclusivity from biosynthetic human growth hormone and erythropoietin. "The proposed amendment would restore credibility and integrity to the Orphan Drug Act by showing that rapacious misuse of its exclusivity provision at the expense of the patient population will not be tolerated by Congress," the document states. Legislation floated and subsequently withdrawn by Sen. Kennedy (D-Mass.) would have permitted removal of exclusivity benefits for products priced unreasonably vis a vis their costs ("The Pink Sheet" Oct. 9, T&G-10). Serono's position paper was developed in response to a memorandum, which the firm said was "circulated by some unknown parties on Capitol Hill" to oppose the Kennedy amendment. Beneficiaries of the Kennedy proposal would include "a Danish and Italian company" (Novo-Nordisk and Serono), the memo states, charging that they "have unclean hands because they continued to market a growth hormone derived from the pituitary glands of cadavers long after that product was banned in the U.S." Serono replied: "Genentech has raised the issue of 'unclean hands.' Its product Protropin is a first-generation bacteria-derived biotechnology product containing an extra amino acid group over the natural growth hormone . . . If Genentech were truly interested in the good of the patient population rather than its own monopolistic profits, it would have no objection to the opening of the marketplace so that patients and doctors would be free to choose which product they feel is most appropriate." Protropin is outselling Lilly's natural-sequence biosynthetic human growth hormone product Humatrope.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts