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Original Source: FD (FAIR DISCLOSURE) WIRE
. Elizabeth Woo, Biogen Idec Inc., VP IR . Jim Mullen, Biogen Idec Inc., CEO . Kelly Martin, Elan Corp, CEO . Burt Adelman, Biogen Idec Inc., EVP Development . Bob Hamm, Biogen Idec Inc., SVP . Gene Mack, HSBC Securities, Analyst . Gordon Francis, Elan Corp, Global Clinical Development . Geoff Meacham, JP Morgan, Analyst . Bill Tanner, Leerink Swann, Analyst . Orla Hartford, NCB, Analyst
. Joel Sendek, Lazard Capital Markets, Analyst . Annie Cheng, JP Morgan, Analyst . Craig Parker, Lehman Brothers, Analyst . Eric Schmidt, Cowen & Co, Analyst . Geoff Porges, Sanford Bernstein, Analyst
. May-Kin Ho, Goldman Sachs, Analyst . Jack Gorman, Davy Stockbrokers, Analyst . Alex Silverstein, Bear Stearns, Analyst . Ron Ellis, Prudential, Analyst . Lawrence Bloomberg, Scout, Analyst . Erica Whittaker, Merrill Lynch, Analyst . David Witzke, Banc of America Securities, Analyst . Oliver Marty, Columbus Circle Investors, Analyst
. Shane Cooke, Elan Corp, CFO
The Co. reported on 06/06/06 that the FDA has decided to allow TYSABRI back in the market and make it available to patients. BIIB believes that the reintroduction of TYSABRI offers new hope as an important therapeutic choice for patients living with a disabling and devastating disease.
S1. Opening Comments (J.M.) 1. Highlights: 1. The Co. reported that the reintroduction of TYSABRI offers new hope as an important therapeutic choice for patients living with a disabling and devastating disease. 2. TYSABRI has demonstrated compelling efficacy in MS, and BIIB believes the TOUCH Prescribing Program designed in collaboration with the FDA will help patients and physicians
assess the benefits and risks of TYSABRI and make informed
decisions about therapy. 3. Patient [testimony] at the FDA advisory committee underscores that MS remains a disease with significant unmet medical need. 4. The Co. believes that appropriate patients can benefit from TYSABRI given its outstanding efficacy and it expects to work diligently to provide physicians and patients with information about the risks and benefits of TYSABRI so they can make informed decisions about their MS therapy.
5. Market Backdrop: 1. Of the 400,000 relapsing MS patients in the US, market research indicates about 200,000 patients in the US are on one of the MS therapies and about half are dissatisfied for either lack of efficacy, side effects, or tolerability. 2. Another 50,000 plus have quit the current therapies and have been waiting many years for new therapeutic options. 2. TOUCH Prescribing Program: 1. The Co. expects that implementing the requirements of the TOUCH Prescribing Program, which is the risk-management plan, will take some time, but it is going to work on that as
quickly as possible. 2. The first step includes finalizing all of the educational material the Co. needs there. 1. Most of this has been finalized with the FDA, but there are a few outstanding pieces of material. 3. The Co. then needs to make sure all the systems are validated so it will have a centralized database at BIIB, which will household this information, which needs to be validated. 4. Then BIIB needs to ensure that its trainers are trained and they in turn will go out to the field and educate prescribers, patients, nurses, and pharmacists about the TOUCH Prescribing Program. 5. The Co. expects to be in position to begin the external training efforts in July. 1. Once a clinical site has been educated and an infusion center has been qualified, then they'll be in a position to begin enrolling patients.
3. Europe: 1. The Co. is expecting EMEA approval in "3Q" and then it expects to start the typical staggered rollout country-by-country as it gets pricing approvals. 2. It will first start with Germany and then rollout to other major markets, launching most of the markets by the 1H07.
S2. Elan's View on TYSABRI (K.M.) 1. Details: 1. The Co. is pleased with the FDA decision to allow TYSABRI back in the market and make it available to patients. 1. In the US, as known, the unmet medical need in MS remains significant with the majority of MS patients continuing to decline clinically. 1. The need which they have and what the Co. heard at the advisory committee remains very significant.
2. Over the last 15 or 16 months, there's been a tremendous
amount of work that has been done by all the respective constituents in this process, including the agency, the teams
of BIIB and Elan, the physicians, and others. 1. The Co. believes that it's been a Herculean effort to take a drug that was approved in an accelerated fashion would have a large effect and impact on patients and go through a safety process to get it back into the position where the Co. is today. 3. Pricing: 1. Since the Co. just got the final word from the FDA on 06/05/06 and over the last several days finalized all the components of the risk map, it expects to make the decision on pricing over the very near future.
2. When that decision is made, the price will be posted on Elan.com, as Elan is accountable for setting the price after appropriate consultation with Elan's partner BIIB and others. 4. Patients:
1. As the Co. heard at the advisory committee, the patient need
is significant, how they live their lives every day. 2. TYSABRI is expected to offer them the option therapeutically of improving their lives and getting back control of their lives. 3. The Co. thinks that with the proper education, the proper implementation of the risk map, TYSABRI over time will certainly be a very significant opportunity for patients who suffer from MS. 5. Europe: 1. Europe remains on track. 2. The discussions are very constructive.
3. Over the course of "3Q", the Co. hopes to hear from the European regulator, then have the commensurate commercial rollout soon thereafter.
S3. Package Insert & Risk Map (B.A.) 1. Label: 1. The indication and [usage] statement says that TYSABRI is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. 2. Because of the increased risk of PML, TYSABRI monotherapy is generally recommended for patients who have had an inadequate response to or are unable to tolerate alternate MS therapies. 3. The decision to start TYSABRI will be based on the individual patient's condition and a decision with his or her physician after being fully informed of the benefits and risks of TYSABRI. 4. The Co. thinks the number one question that it has gotten relates to whether this indication statement disallows early therapy for patients with TYSABRI. 1. [Rusty Cats], the head of the review group at the FDA that approved the product, is saying that there's nothing in the risk map plan that absolutely precludes the use of TYSABRI
as first-line therapy. 2. The largest components of the market are individuals who have been on therapy and for one reason or another are in search of new therapy. 3. There will undoubtedly be instances where physicians and patients decide that TYSABRI is appropriate therapy for early …