March  2002                   

From:   MURO                                                                                          

MURO Pharmaceutical, Inc.

Muro Pharmaceutical, Inc., is pleased to introduce a new line extension of OPTIVAR™ (azelastine hydrochloride ophthalmic solution, 0.05%) in a convenient 3 mL size (25 days of supply) to treat the itch associated with allergic conjunctivitis in adults and children 3 years of age or older.  The market for OPTIVAR™ continues to grow at double digit levels to over $200 million in 2002.  The new 3 mL size will meet the seasonal needs of the allergic conjunctivitis patients allowing for at least a 25 day supply of product.  The OPTIVAR™ 6 mL (50 days of supply) will continue to meet the needs of perennial users with the economy of a larger size.

Azelastine hydrochloride is a relatively selective histamine H₁ antagonist / mast cell stabilizer and an inhibitor of the release of histamine and other mediators from cells involved in the allergic response.  Based on in-vitro studies using human cell lines inhibition of other mediators involved in allergic reactions (e.g. leukotrienes' and Platelet Activating Factor) has been demonstrated with azelastine hydrochloride.  Decreased chemotaxis and activation of eosinophils has also been demonstrated.

The safety and efficacy of OPTIVAR™ were evaluated in 19 trials in a total of 1,220 patients.  the unique characteristics of OPTIVAR™ allow this product to have a rapid onset of action (within 3 minutes) and a long duration of effect (approximately 8 hours) with twice daily dosing.

In controlled, multidose studies, the most frequently reported adverse events were transient eye burning/stinging, headache, and bitter taste.  The occurrence of these events was generally mild.  No serious adverse events were reported.

MURO Pharmaceutical, Inc.    

Muro Pharmaceutical's Tri-Nasal® (triamcinolone actonide, USP) Nasal Spray, 50 mcg, is the newest, FDA approved, intranasal steroid for the once-daily treatment of nasal symptoms associated with both seasonal and perennial allergic rhinitis in adults and children twelve years of age and older.  Tri-Nasal Spray is an aqueous, fragrance-free solution of triamcinolone acetonide, the same active ingredient contained in Nasacort® AQ and Nasacort® Nasal Inhaler.

The efficacy and safety of Tri-Nasal® Nasal Spray in both seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) have been well established in 14 clinical trials (n=1,187 patients).  In one clinical trial, both Tri-Nasal® Nasal Spray and Nasacort®  Nasal Inhaler were studied in 397 patients with SAR.  Results showed that a once-daily dose of Tri-Nasal®  Nasal Spray was effective in relieving the nasal symptoms (rhinorhea sneezing and nasal congestion) associated with SAR.  In addition, the extent of improvement with the 400 mcg once-daily dose of Tri-Nasal® Nasal Spray was comparable to that of the 400 mcg once-daily dose of Nasacort® Nasal Inhaler.

Some additional benefits of Tri-Nasal® Nasal Spray include:

• Lowest-priced intranasal steroid (up to 33% cost-savings versus Nasacort AQ/Nasacort® Nasal Inhaler)

• Low incidence of epistaxis, 0.5% at the 200 mcg once-daily dose

• No shaking required

• Dosing consistency provided with each dose

The usual starting dose of Tri-Nasal® Nasal Spray is 200 mcg given once daily.  Each 15-mL bottle of Tri-Nasal® Nasal Spray contains a total of 120 sprays (a 30-day supply) with each spray delivering 50 mcg of triamcinolone acetonide.  The maximum daily dose of Tri-Nasal® Nasal Spray is 400 mcg.

The most commonly reported adverse events with Tri-Nasal® Nasal Spray were: headache, pharyngitis, taste perversion and back pain.  The incidences of these adverse events, the majority of which were mild to moderate and transient, were comparable to those reported for vehicle placebo.  Less than 1% of patients discontinued due to nasal burning or stinging.  For complete prescribing information on Tri-Nasal® Nasal Spray, see the package insert.

Please feel free to contact Muro's Medical Services Department (800-225-0974 x2565) for additional information regarding Tri-Nasal® Nasal Spray.

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June 2002                                  

From: SIDMAK

It is my pleasure to announce that Sidmak Laboratories, Inc., and its wholly owned subsidiary, Odyssey Pharmaceuticals, Inc., have been acquired by PLIVA d.d., Croatia.

PLIVA, the largest pharmaceutical company in Central and Eastern Europe, is a unique company with investments in both research and development (R&D).  With recent acquisitions of pharmaceutical and R&D companies in Poland, the Czech Republic, France, Germany, Denmark, and the UK, PLIVA is in possession more than 400 patents, and with development of new chemical entity (NCE) and generic pharmaceutical products PLIVA is well-positioned for sustained growth.

With the acquisition of Sidmak and Odyssey, PLIVA will now have its first major presence in the USA.  Although it has licensed several products to major American pharmaceutical companies- particularly with its discovery of the macrolide antibiotic azithromycin- to date PLIVA has not been involved directly with the manufacture, sales, or distribution of finished products for human use within the USA.

This exciting and timely acquisition by PLIVA will strengthen the Sidmak tradition of marketing innovative, high-quality, and timely new products.  It is a perfect fit with the strategic goals, direction, and vision that have been developed for Sidmak and Odyssey.  PLIVA will facilitate Sidmak becoming a leading Specialty Pharmaceutical Company over the next couple of years, and with its operations in Europe PLIVA allows us the opportunity to expand this effort globally.  In addition, the strong development capabilities of PLIVA will provide the addition of many new generic pharmaceuticals to our expanding product portfolio - including generic versions of biotech pharmaceuticals.

The acquisition is a value-added and synergistic transaction for both PLIVA and Odyssey in the branded pharmaceutical activities.  Not only will PLIVA facilitate the very important strategy implemented by Odyssey of adding brand-name pharmaceuticals to its product portfolio, but Odyssey will offer its expanding line of brand-name products to PLIVA for markets outside the USA.

The bottom line: The changes that will occur at Sidmak/odyssey will be those that benefit you in the short and long term.

I would like to take this opportunity to thank you for your ongoing support of Sidmak and Odyssey.  I am confident that with our acquisition by PLIVA a win-win relationship will evolve for all.

Please feel free to contact the Sidmak/Odyssey sales department, or me, at 800-922-0547, should you have any questions or concerns relating to this important development.

Sincerely,

Paul D. Cottone                                                                                                                                                               President & CEO                                                                                                                                                              Sidmak Laboratories/Odyssey Pharmaceuticals

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