October 21, 2004

IN BRIEF: MEDIMMUNE INC.

MedImmune Inc. initiated a Phase III trial to compare its refrigerator-stable intranasal influenza vaccine with the injectable flu shot. The study will include approximately 7,000 children aged 6 months through 59 months and will evaluate the vaccines' efficacy during the upcoming flu season. MedImmune has also initiated a study to compare its refrigerator-stable vaccine with its currently marketed frozen formulation, pharma brand FluMist. October 6, 2004

UK REGULATORY AUTHORITY SUSPENDS CHIRON'S FLUVIRIN MANUFACTURING LICENSE; COMPANY WILL NOT RELEASE FLUVIRIN FOR 2004-2005 FLU SEASON

The Medicines and Healthcare Products Regulatory Agency (MHRA), the regulatory body in the United Kingdom, temporarily suspended Chiron Corp.'s license to manufacture Fluvirin influenza vaccine, preventing the company from releasing the product for use during the 2004-2005 flu season.

In a review of the company's test data and manufacturing processes at the Liverpool facility, the MHRA determined the company's processes do not comply with UK Good Manufacturing Practices. Chiron originally anticipated the review process would be completed satisfactorily, in time to allow for the release of the Fluvirin vaccine in early October.

Chiron was expected to supply the United States with nearly half the U.S. flu vaccine supply for the upcoming flu season, accounting for between 46 million and 48 million doses, according to CBS MarketWatch. The company said it has contacted the Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) regarding the situation and is discussing the potential impact with the agencies.

In a statement released Tuesday, the U.S. Department of Health and Human Services said that it currently expects to receive approximately 54 million flu vaccine doses from Aventis SA and an additional 1 million to 2 million FluMist doses from MedImmune Inc.

HHS also noted that its immediate focus will be on ensuring the supply the United States has is available to those who are most vulnerable to the disease. The determination of who should receive the pharma brand flu vaccine this season, based on the new vaccine supply information, will be made by the CDC's Advisory Committee on Immunization Practices.

As a result of the license suspension, the company lowered its financial guidance for fiscal 2004. Chiron expects the suspension to negatively impact pro-forma and Generally Accepted Accounting Principles earnings per share by $1.10 to $1.15. Consequently, the firm's updated 2004 guidance is now between $0.70 and $0.80 per share on a pro-forma basis ($0.35 and $0.45 per share on a GAAP basis).

Shares of Chiron closed at $37.98, down $7.44, or 16.4 percent, in heavy Nasdaq trading.

July 26, 2004

MEDIMMUNE RECORDS $100.3 MILLION NET LOSS IN SECOND QUARTER

MedImmune Inc. reported a $100.3 million, or $0.40 per share, net loss, for the second quarter of 2004, representing a drop from a net profit of $13.5 million, or $0.05 per share, in the second quarter of last year.

The company attributed the loss primarily to the termination of agreements with Wyeth concerning inhaled influenza vaccine FluMist. Excluding the charges associated with the termination of these agreements, MedImmune's net loss for the second quarter of 2004 was $29 million, or $0.12 per share.

Total revenue for the quarter reached $94 million, which was higher than analyst predictions, according to TheStreet.com, but lower than the $113 million achieved during the second quarter of last year.

Product sales increased 13 percent to $91 million, which MedImmune attributed to a 10 percent increase in sales of respiratory drug Synagis (palivizumab). Compared to the second quarter of 2003, sales of cytomegalovirus infection drug CytoGam (cytomegalovirus immune globulin intravenous, human) grew by 123 percent to $8 million.

Shares of MedImmune closed at $22.51, down $0.67, or 2.9 percent, after moderate trading on the Nasdaq.

Monday, June 30, 2003

IN BRIEF: MEDIMMUNE INC.

MedImmune Inc. reconfirmed its full-year guidance and increased its guidance for the second quarter. The Gaithersburg, Md.-based firm increased its second-quarter adjusted earnings to between $0.02 per diluted share and $0.05 per share and its revenue to between $110 million and $120 million. MedImmune said it expects the recent approval of its nasal-spray flu vaccine FluMist to help drive its revenue and earnings growth.

June 18, 2003

FDA APPROVES MEDIMMUNE'S FLUMIST

The Food and Drug Administration approved MedImmune Inc.'s FluMist, the first nasal-spray flu vaccine to become available in the United States.

The product also represents the first live-virus influenza vaccine approved by the FDA, the agency said.

FluMist is approved for the prevention of influenza in individuals aged 5 to 49 years. Children aged 5 to 8 years need two doses at least six weeks apart in their first year of vaccination with FluMist. Patients aged 9 to 49 years only need one dose.

MedImmune will co-market FluMist with Wyeth Vaccines, a business unit of Wyeth Pharmaceuticals.

FluMist was originally developed by Aviron, a California-based biotechnology firm that MedImmune acquired in January 2002.

In July 2001, an FDA advisory panel said that FluMist was effective in preventing the flu, but that there was insufficient evidence to alleviate concerns about using the live flu virus in the spray. However, after MedImmune presented more data, another panel recommended FDA approval last December.

Analysts have various sales predictions for FluMist, Reuters reported. Most predict sales of $100 million to $150 million during the first year, and as much as $800 million by 2006.

Each year, influenza infects an estimated 17 million to 50 million Americans, MedImmune reported.

Shares of MedImmune closed at $38.71, down $1.02, or 2.6 percent, in heavy Nasdaq trading. Shares of Wyeth closed at $49.16, up $1.72, or 3.6 percent, in moderate trading on the New York Stock Exchange.

June 16, 2004

MEDIMMUNE CUTS FLUMIST PRICE, NAMES DISTRIBUTOR FOR 2004 FLU SEASON

MedImmune Inc. reduced the price of FluMist (influenza virus vaccine live, intranasal) by approximately 50 percent to $23.50 per returnable dose and named Henry Schein Inc. as the exclusive U.S. distributor of the vaccine for the upcoming flu season.

Henry Schein will process all customer product inquiries and returns and will promote the product to primary care physicians. MedImmune will oversee all sales and marketing activities with particular emphasis on pediatricians and pharmacies, according to a press release.

The product will also be available through Henry Schein's Caligor Medical and General Injectables & Vaccines businesses. Henry Schein is ready to accept orders for the product, which will ship starting in late summer of this year.

As reported, in February, MedImmune estimated FluMist revenue for the 2003-2004 flu season would be $76 million, according to The Associated Press. MedImmune had lowered its outlook after the vaccine's launch proved uneventful, the AP said.

Then in April, the company projected between $1.1 billion and $1.15 billion in overall revenue, including FluMist sales in the range of $35 million to $45 million. Also during this time, MedImmune and Wyeth ended their collaboration for FluMist, consequently returning worldwide rights and full responsibility for the manufacture, marketing and distribution of FluMist to MedImmune.

The companies said they believed the arrangement would provide a "substantial opportunity" for each company to better meet their respective financial and operational goals.

May 5, 2004

FLUMIST REFRIGERATOR-STABLE FORMULATION MAY BE MORE EFFECTIVE AT REDUCING INFLUENZA AMONG PEDIATRIC PATIENTS

Results from two Phase III studies indicate that a refrigerator-stable formulation of MedImmune Inc.'s FluMist (influenza virus vaccine live, intranasal), known as CAIV-T, was more effective than the traditional flu vaccine and had a similar safety profile.

Before the 2002-2003 flu season, approximately 2,200 pediatric patients aged 6 to 71 months who had a history of recurrent respiratory tract infections received two doses of CAIV-T or the traditional flu vaccine.

When compared with patients who received the traditional vaccine, CAIV-T-treated patients had a 53 percent reduction in flu incidence as confirmed by culture.

In a second trial conducted at nearly the same time, approximately 2,200 pediatric patients aged 6 to 17 years with an asthma history received one dose of CAIV-T or the traditional vaccine. There was a 35 percent reduction in culture-confirmed flu among the patients who were treated with CAIV-T compared with those who received the traditional vaccine.

Furthermore, post-vaccination rates of wheezing were not significantly different between the two treatment groups.

These studies were presented in San Francisco at the Pediatric Academic Societies' annual meeting.

April 28, 2004

MEDIMMUNE, WYETH TERMINATE FLUMIST COLLABORATION

MedImmune Inc. and Wyeth ended their collaboration for the nasal flu vaccine FluMist, consequently returning worldwide rights and full responsibility for the manufacture, marketing and distribution of FluMist to MedImmune.

The companies said they believe the arrangement will provide a "substantial opportunity" for each company to better meet their respective financial and operational goals.

As part of the dissolution of the agreement, which also includes an investigational second-generation liquid formulation named Cold Adapted Influenza Vaccine-Trivalent (CAIV-T), MedImmune will acquire Wyeth's Louisville, Ky., distribution facility. Wyeth will also provide bulk manufacturing materials and services and will transfer clinical trial data to MedImmune during the transition period.

Furthermore, MedImmune will pay Wyeth an upfront payment, milestone payments upon achievement of certain regulatory and development targets and pay royalties on future FluMist sales.

The dissolution of the agreement is expected to be finalized by the fourth quarter of 2004.

As a result of the termination, MedImmune updated its 2004 guidance. The company now expects to recognize a one-time $73 million charge in the second quarter to write off unamortized intangibles associated with the agreement.

For the year, the company projects between $1.1 billion and $1.15 billion in revenue, including FluMist sales in the range of $35 million to $45 million. Diluted earnings per share are expected to be between $0.06 and $0.12. However, during the second quarter, MedImmune expects a loss in earnings per share of between $0.48 and $0.52.

Shares of MedImmune closed at $25.71, up $1.64, or 6.8 percent, in heavy trading on the Nasdaq, while Wyeth shares closed at $39.27, down $0.23, or 0.5 percent, in light trading on the New York Stock Exchange.

April 24, 2003

WYETH PROFIT EXCEEDS ANALYSTS' PREDICTIONS; SHARES GAIN

Wyeth shares climbed 11.6 percent after the drug maker posted first-quarter earnings that topped analysts' expectations.

Net income for Wyeth totaled $1.28 billion, or $0.96 per diluted share, in the first quarter of 2003. In the same period of 2002, net income was $871.9 million, or $0.65 per share.

Wyeth said profit was boosted by gains from the sale of its stake in Amgen Inc.; the company recorded a $558.7 million after-tax gain from the sale of its remaining shares of Amgen common stock holdings.

Excluding the Amgen gain, net profit was down 18 percent to $719.2 million, or $0.54 per share; analysts polled by Reuters Research had predicted earnings of $0.52 per share.

Total revenue increased 1 percent to $3.7 billion, helped by a favorable effect of foreign currency, Wyeth noted. Worldwide sales of prescription drugs, meanwhile, reached $2.98 billion.

With respect to 2003 earnings, Wyeth said in a conference call that strong sales of its newer pharma brand therapies should enable it to meet its earnings target of between $2.40 per share and $2.50 per share, Reuters reported.

The firm added that it expects Food and Drug Administration approval of its flu vaccine Flumist in the second quarter. Furthermore, it anticipates that "within weeks to months," the FDA will approve a low-dose version of its hormone replacement therapy Premarin (conjugated estrogens/ medroxyprogesterone).

Shares of Wyeth closed at $40.05, up $4.15, in heavy trading on the New York Stock Exchange.

April 22, 2004

MEDIMMUNE SAYS Q1 REVENUE UP 13 PERCENT, BUT REITERATES LOWERED GUIDANCE FOR Q2

MedImmune Inc. said its total revenue for the first quarter of 2004 grew 13 percent to $489 million, primarily due to increased worldwide sales of its respiratory drug Synagis (palivizumab) during the quarter.

Synagis generated $422 million in 2004 first-quarter sales, up from $391 million in the first quarter of 2003.

Meanwhile, net earnings for the latest quarter totaled $111 million, or $0.44 per diluted share, compared with net earnings of approximately $110 million, or $0.43 per share, during the prior-year period.

MedImmune also recognized $31 million in revenue related to its flu vaccine FluMist (influenza virus vaccine live, intranasal), including transfer payments, royalties and reimbursements from Wyeth, the company's co-promotion partner for the vaccine. On March 1, MedImmune announced that discussions are ongoing with Wyeth regarding its continued involvement, if any, in the development and commercialization of FluMist.

Gross margins on product sales during the first quarter of 2004 were 67 percent, down 9 percentage points from the same period in 2003. The company said this decrease was due to the impact of 2003/2004 FluMist seasonal sales and cost of sales recognized in the first-quarter of 2004, as well as a "write-down of the 2004/2005 FluMist seasonal inventory."

MedImmune did reiterate, however, that it expects a loss of $0.13 to $0.16 per share in the second quarter of 2004.

Shares of MedImmune closed at $24.29, up $0.55, or 2.3 percent, in heavy Nasdaq trading.