February 01, 2005

IN BRIEF: MYLAN LABORATORIES INC.

Mylan Laboratories Inc. said the Food and Drug Administration granted Mylan Technologies Inc. final approval of its abbreviated New Drug Application for fentanyl transdermal system, a pain relief patch. According to Reuters, Mylan's pharma brand is the first generic rival to Duragesic, which is manufactured by Alza Corp., a subsidiary of Johnson & Johnson. Mylan said the generic version is approved in 25 mcg/hour, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr strengths and will ship immediately.

December 2, 2004

IN BRIEF: CEPHALON INC.

Cephalon Inc. filed a supplemental New Drug Application with the Food and Drug Administration, seeking approval of a sugar-free formulation of Actiq (oral transmucosal fentanyl citrate). The currently marketed formulation of Actiq is approved for the management of breakthrough pain in cancer patients who are receiving opioid therapy and are tolerant of opioid therapy. If approved, the sugar-free formulation would be marketed for the same indication. Cephalon said the FDA's targeted review period for sNDAs of this type is four months. March 29, 2004

October 13, 2004

J&J REPORTS 13 PERCENT THIRD-QUARTER EARNINGS GROWTH

Johnson & Johnson's third-quarter net earnings and sales in 2004 increased 13 percent and 10.5 percent, respectively, as compared with the same period of last year.

Net earnings reached $2.34 billion, or $0.78 per diluted share, in the third quarter of 2004 compared with $2.07 billion, or $0.69 per share, in the prior-year quarter.

Overall sales totaled $11.55 billion, up from $10.45 billion in 2003.

Worldwide pharmaceutical sales increased 13.4 percent to reach $5.49 billion, while U.S. pharmaceutical sales gained 12.5 percent to $3.69 billion.

According to The Wall Street Journal, the gain in pharmaceutical brand revenue was due in part to increased sales of the antipsychotic Risperdal (risperidone), which were up 25 percent to $746 million; pain patch Duragesic (fentanyl), up 27 percent to $536 million; and arthritis and Crohn's disease drug Remicade (infliximab), up 23 percent to $545 million. Sales of anemia drug Procrit (epoetin alfa), on the other hand, fell 12 percent to $887 million.

Medical device and diagnostic sales grew 7 percent to $4.04 billion worldwide in the third quarter, while U.S. sales dropped 3.4 percent to $2.07 billion. According to TheStreet.com, U.S. sales of J&J's Cypher sirolimus-eluting coronary stent dropped 37 percent in the quarter to $269 million, as Boston Scientific Corp.'s Taxus Express2 paclitaxel-eluting stent dominated the U.S. market for drug-coated stents.

J&J shares closed at $56.82, up $1.46, or 2.6 percent, in heavy trading on Wall Street.

September 8, 2004

IN BRIEF: CEPHALON INC.

Cephalon Inc. said it received a subpoena from the U.S. Attorney's Office in Philadelphia requesting documents, dating from 1998 to the present, regarding sales and promotional practices for the firm's wakefulness drug Provigil (modafinil), cancer pain drug Actiq (oral transmucosal fentanyl citrate) and seizure drug Gabitril (tiagabine hydrochloride), CBS MarketWatch reported. Cephalon said it plans to cooperate with the request. Shares of Cephalon closed at $45.88, down $2.00, or 4.2 percent, in heavy trading on the Nasdaq.

August 11, 2004

FTC GRANTS CLEARANCE FOR CEPHALON TO ACQUIRE CIMA

Cephalon Inc.'s consent agreement regarding the company's acquisition of Cima Labs Inc. was accepted by the Federal Trade Commission, which will allow Cephalon to complete the acquisition within the next few days.

As part of the transaction, Cephalon will acquire Cima's OraVescent fentanyl, which is currently being studied in Phase III trials as a treatment for breakthrough cancer pain.

Cephalon believes the agent, which utilizes Cima's enhanced absorption transmucosal drug-delivery technology to provide a rapid onset of pain relief, will be more appealing and gain greater market penetration than its own pain product Actiq CII (oral transmucosal fentanyl citrate).

Cephalon will not be required to divest Actiq as part of the merger and will retain marketing rights. The company will grant a license to Barr Laboratories Inc. for any remaining intellectual property related to the compound.

The license will become effective Feb. 3, 2007, if Cephalon obtains pediatric exclusivity or Sept. 5, 2006, if it does not. However, the license could become effective even earlier if Cephalon gains approval from the Food and Drug Administration for OraVescent (fentanyl) prior to those dates.

Barr said the agreement requires Cephalon to supply it with a Cephalon-manufactured product for resale if Barr cannot obtain FDA approval of an Abbreviated New Drug Application for the product before the license's effective date.

Additionally, once OraVescent is approved, Barr may also obtain rights to the sugar-free formulation of Actiq, for which Cephalon expects to file a supplemental New Drug Application later this year.

As a result of the acquisition, Cephalon increased its 2004 sales guidance by $15 million to between $915 million and $965 million. It also raised third-quarter sales guidance by $5 million to between $250 million and $260 million. The previously issued earnings-per-diluted-share guidance for the third quarter and full year remain the same.

Shares of Cephalon closed at $43.00, down $4.86, or 10.2 percent, in heavy trading on the Nasdaq. Cima shares closed at $33.97, up $0.26, or 0.77 percent, in heavy trading on the Nasdaq. Barr shares closed at $37.72, up $1.01, or 2.8 percent, in moderate trading on the New York Stock Exchange.

July 28, 2004

IN BRIEF: ALZA CORP.

Alza Corp. received an approvable letter from the Food and Drug Administration for Ionsys, an iontophoretic, fentanyl-containing transdermal analgesic. Alza submitted a New Drug Application for the product last September. The firm, a Johnson & Johnson company, added that it is working as quickly as possible to address the letter.

July 14, 2004

J&J REPORTS EARNINGS, SALES ROSE DURING SECOND QUARTER OF 2004

Johnson & Johnson's second-quarter 2004 worldwide sales rose 11.1 percent to $11.48 billion from $10.33 billion in the prior-year period as a result of 8.5 percent operational growth and a 2.6 percent currency impact.

"Despite intense competition on several fronts, our corporation continues to achieve solid operational growth," said Chief Executive Officer William Weldon. "We had strong performances from a number of our operating companies within each segment of our business."

Total pharmaceutical sales reached $5.43 billion, up 11.1 percent from $4.88 billion one year ago. Strong sales of rheumatoid arthritis and Crohn's disease drug Remicade (infliximab), epilepsy drug Topamax (topiramate), pain patch Duragesic (fentanyl transdermal system), antipsychotic Risperdal (risperidone) and cardiology drug Natrecor (nesiritide) contributed to the increase in drug sales.

Worldwide sales in the firm's medical devices and diagnostics division rose 11.8 percent from $3.63 billion to $4.06 billion, aided by sales of several products, including foreign sales of Cordis Corp.'s Cypher sirolimus-eluting stent.

Second-quarter net earnings rose to $2.5 billion, or $0.82 per diluted share, beating the $0.79 forecast of analysts surveyed by Thomson Financial, according to CBS MarketWatch. During the second quarter of 2003, the company's $1.21 billion, or $0.40 per share, in net earnings included a $900 million in-process research and development charge for costs related to J&J's acquisitions of Scios Inc. and Link Spine Group Inc. Excluding this charge, net earnings rose 16.5 percent this past quarter, or 17.1 percent per share.

June 24, 2004

MYLAN SUES FDA, SUSPENDS EARNINGS GUIDANCE AFTER JANSSEN RECEIVES EXTENSION OF DURAGESIC EXCLUSIVITY

Mylan Laboratories Inc. filed a lawsuit against the Food and Drug Administration and suspended its annual earnings guidance after the regulatory agency decided to apply a six-month period of pediatric exclusivity to Janssen Pharmaceutica Product L.P.'s Duragesic (fentanyl transdermal system) CII pain patch.

Mylan alleges that in making this decision, the FDA acted against sections of the Federal Food, Drug and Cosmetic Act, the Administrative Procedures Act, published regulations and legal precedent. Additionally, Mylan said the decision "encourages branded pharmaceutical companies to ignore the 45-day timeline to sue and effectively eliminates a generic company's ability to challenge patents that are nearing expiration," said Robert Coury, Mylan's chief executive officer.

"Regardless of whether the FDA sided with Mylan or Janssen Pharmaceutica in its interpretation, we anticipated the courts would ultimately resolve this issue and believe the judicial process will result in confirmation of our position," he added.

A hearing in the suit must be held prior to July 23, based on local procedural rules, Mylan said; therefore, the firm suspended its earnings guidance.

In May, Mylan confirmed an earnings forecast of between $1.30 and $1.40 per share for the year ending March 2005, assuming the firm's generic Duragesic would launch on July 24. The new pediatric exclusivity period requires the FDA to change the effective date of its approval for Mylan's generic version to after January 2005, Janssen said.

FDA spokeswoman Kathleen Quinn said, "We can't comment directly on lawsuits but this is something that obviously is a difference of opinion in interpreting regulation."

In November, the FDA granted final approval to Mylan's version of the drug. However, in March, a federal court in Vermont ruled that Mylan's product infringed Janssen's product and extended Janssen's marketing exclusivity to July.

Alza Corp., which like Janssen is a Johnson & Johnson company, holds the product patent, although Janssen markets Duragesic in the United States.

Shares of Mylan closed at $20.86, down $1.56, or 7 percent, in heavy trading on the New York Stock Exchange.

March 29, 2004

IN BRIEF: JANSSEN PHARMACEUTICAL PRODUCTS L.P.

Janssen Pharmaceutical Products L.P. announced that the U.S. District Court of Vermont upheld the validity of Alza Corp.'s Duragesic (fentanyl transdermal system) CII product patent. The court ruled that Mylan Laboratories Inc.'s proposed Abbreviated New Drug Application for a generic pain relief patch infringed on the product's patent. Janssen said if the Food and Drug Administration approves Mylan's ANDA, the effective date must occur after the July 2004 expiration of the Duragesic patent. Mylan plans to appeal the decision. Duragesic is marketed in the United States by Janssen and Alza holds the product's patent.

August 5, 2003

CEPHALON REPORTS INCREASED Q2 EARNINGS BEHIND STRONG PROVIGIL SALES

Cephalon Inc. reported growth in earnings in the second quarter of 2003 as sales of its Provigil (modafinil) narcolepsy therapy jumped 40 percent as compared with sales in the same quarter of last year.

In this year's second quarter, the company's net income reached approximately $18.1 million, or $0.31 per diluted share, up from net income in the prior-year quarter of nearly $14.4 million, or $0.25 per share.

Total revenue for the quarter climbed to $168.8 million compared with revenue of $120.7 million in the second quarter of 2003.

Specifically, sales of Provigil increased 40 percent to $69.5 million, while sales of cancer-pain therapy pharma name Actiq (fentanyl) rose 85 percent to $52.7 million.

The company also reiterated its 2003 full-year earnings guidance of between $650 million and $660 million, and adjusted diluted EPS guidance of approximately $1.50 after taxes.

Cephalon released its earnings report after U.S. stock markets closed Monday.

May 9, 2003

CEPHALON Q1 REVENUE FALLS BELOW EXPECTATIONS

Cephalon Inc. reported increases in first-quarter earnings and revenue, but the company's drug sales fell short of expectations, causing an 8.6 percent drop in shares.

The West Chester, Pa-based drug maker earned $12.2 million, or $0.21 per share, in the first quarter of 2003 compared with a loss of $2.9 million, or $0.05 per share, in the same period of 2002. According to Reuters Research, the company had been expected to earn $0.20 per share.

Total revenue reached $144.7 million in the first quarter compared with $111.5 million in the year-ago period. Analysts, on average, had been expecting $153.5 million in quarterly revenue.

Furthermore, product sales totaled $137.6 million, an increase of 44 percent from $95.8 million in 2002. However, that figure was also short of projections.

Sales of narcolepsy drug Provigil (modafinil), breakthrough cancer pain therapy pharmaceutical brand Actiq (fentanyl) and epilepsy treatment Gabitril (tiagabine) all rose, with Actiq posting the highest increase, at 139 percent over the prior-year quarter.

The company said its sales growth moderated in the quarter due to realignment and expansion of its sales force.

However, with the changes complete, Cephalon reiterated its full-year guidance for product sales of between $650 million and $660 million, and earnings of $1.50 per share.

Shares of Cephalon closed at $38.65, down $3.63, in heavy trading on Nasdaq.