TAGI Pharma Announces Exclusive Marketing Rights Agreement for Alendronate Sodium Oral Solution, 70mg/75ml x 4 Pack Unit of Use

TAGI Pharma Announces Exclusive Marketing Rights Agreement for Alendronate
Sodium Oral Solution, 70mg/75ml x 4 Pack Unit of Use

SOUTH BELOIT, Ill., April 30, 2013 (GLOBE NEWSWIRE) -- TAGI Pharma, Inc., a
specialty pharmaceutical company and subsidiary of Precision Dose, Inc.,
announced today the signing of an exclusive marketing rights agreement to
market and sell the approved ANDA product, Alendronate Sodium Oral Solution,
70mg/75mL in the United States and its territories, possessions and
protectorates.

Alendronate Sodium Oral Solution, 70mg/75mL is the only FDA approved generic
alternative to Merck & Co., Inc.'s FOSAMAX® (alendronate sodium) oral solution
product. Alendronate Sodium Oral Solution is a bisphosphonate, and indicated
for the (1) treatment of osteoporosis in postmenopausal women, and (2)
treatment to increase bone mass in men with osteoporosis. Alendronate Sodium
Oral Solution is contraindicated in patients (1) with abnormalities of the
esophagus which delay emptying such as stricture or achalasia, (2) with
inability to stand/sit upright for at least 30 minutes, (3) at increased risk
of aspiration, (4) with hypocalcemia, (5) with hypersensitivity to any
components of this product. (See the accompanying prescribing information for
additional safety and product information.)

Thomas Anderson, Executive President and responsible for TAGI's Business
Development activities, said, "This agreement represents an additional step
forward in the implementation of TAGI Pharma's business plan to bring
differentiated products to the marketplace, utilizing an aggressive business
development initiative to license, acquire and co-develop products." Kenny
Harrington, Vice President of Sales and Marketing of TAGI Pharma, said "The
Alendronate Sodium Oral Solution product addresses unmet needs in the market
for a liquid Alendronate Product, and complements TAGI's strategy to provide
unique products to underserved customers. We expect to have the Alendronate
Sodium Oral Solution product available for shipment to our customers in May,
but our website (www.tagipharma.com) will be updated with the exact date as we
get closer to launch."

About TAGI Pharma, Inc. and Precision Dose, Inc.

"TAGI Pharma, Inc. was established to target the generic retail market," said
Thomas Anderson, "and our product selection for TAGI Pharma is focused on
higher barriers to entry and limited competition, where there are market
expansion opportunities in the retail market, as well as the non-retail sector
currently being serviced by Precision Dose."

Precision Dose was established in 2003, and continues to work with the
products of prescription and non-prescription liquid manufacturers, as well as
its own products, to add value through its unique unit dose delivery systems,
servicing the hospital and long term care markets. "With its unique line of
liquid unit dose products, Precision Dose continues to expand market share by
meeting customers' needs to eliminate dispensing errors, improve inventory
control and achieve cost containment. We are uniquely positioned in the
marketplace, leveraging the customer relationships of both companies, and
thereby optimizing the market opportunities for our products," said Robert
Koopman, President and CEO of both TAGI Pharma and Precision Dose, Inc.

BRIEF SUMMARY

This brief summary does not include all the information needed to use
Alendronate Sodium Oral Solution safely and effectively. Please see package
insert for full prescribing information for Alendronate Sodium Oral Solution.

ALENDRONATE SODIUM ORAL SOLUTION

70 mg/75 mL

DESCRIPTION

Each bottle of Alendronate Sodium Oral Solution contains 91.35 mg of
alendronate monosodium salt trihydrate, which is the molar equivalent to 70 mg
of free acid.

INDICATIONS

Alendronate Sodium Oral Solution is a bisphosphonate indicated for the
treatment of osteoporosis in postmenopausal women and to increase bone mass in
men with osteoporosis.

DOSAGE AND ADMINISTRATION

For the above indications, the recommended dosage is one bottle of 70 mg oral
solution once weekly.

Alendronate Sodium Oral Solution must be taken at least one-half hour before
the first food, beverage, or medication of the day, followed by at least 2 oz
of plain water. Alendronate Sodium Oral Solution should only be taken upon
arising for the day. Patients should not lie down for at least 30 minutes and
until after their first food of the day. Alendronate Sodium Oral Solution
should not be taken at bedtime or before arising for the day. Failure to
follow these instructions may increase the risk of esophageal adverse
experiences.

CONTRAINDICATIONS

  *Abnormalities of the esophagus which delay esophageal emptying such as
    stricture or achalasia
  *Inability to stand or sit upright for at least 30 minutes
  *Do not administer Alendronate Sodium Oral Solution to patients at
    increased risk of aspiration.
  *Hypocalcemia
  *Hypersensitivity to any component of this product. Hypersensitivity
    reactions including urticaria and angioedema have been reported.

WARNINGS AND PRECAUTIONS

Upper Gastrointestinal Adverse Reactions

Alendronate Sodium Oral Solution, like other bisphosphonates administered
orally, may cause local irritation of the upper gastrointestinal mucosa.
Because of these possible irritant effects and a potential for worsening of
the underlying disease, caution should be used when Alendronate Sodium Oral
Solution is given to patients with active upper gastrointestinal problems.
Esophageal adverse experiences have been reported in patients receiving
treatment with oral bisphosphonates. In some cases these have been severe and
required hospitalization.

Mineral Metabolism

Hypocalcemia must be corrected before initiating therapy with Alendronate
Sodium Oral Solution. Other disorders affecting mineral metabolism (such as
vitamin D deficiency) should also be effectively treated. In patients with
these conditions, serum calcium and symptoms of hypocalcemia should be
monitored during therapy with Alendronate Sodium Oral Solution

Musculoskeletal Pain

In post-marketing experience, severe and occasionally incapacitating bone,
joint, and/or muscle pain has been reported in patients taking bisphosphonates
that are approved for the prevention and treatment of osteoporosis.
Discontinue use if severe symptoms develop.

Osteonecrosis of the Jaw

Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally
associated with tooth extraction and/or local infection with delayed healing,
and has been reported in patients taking bisphosphonates. Known risk factors
for osteonecrosis of the jaw include invasive dental procedures, diagnosis of
cancer, concomitant therapies, poor oral hygiene, and co-morbid disorders.

Atypical Subtrochanteric and Diaphyseal Femoral Fractures

Atypical, low-energy, or low trauma fractures of the femoral shaft have been
reported in bisphosphonate-treated patients.

Renal Impairment

Alendronate Sodium Oral Solution is not recommended for patients with
creatinine clearance <35 mL/min.

ADVERSE REACTIONS

The most frequently observed adverse reactions with Alendronate Sodium Oral
Solution administration during clinical trials include abdominal pain,
musculoskeletal pain, nausea, dyspepsia, constipation, diarrhea, flatulence,
headache, and acid regurgitation. Other adverse reactions include allergic
reactions, rash, pruritis, and rarely severe skin reactions, including
Stevens-Johnson syndrome and toxic epidermal necrolysis.

To report SUSPECTED ADVERSE REACTIONS, contact Roxane Laboratories, Inc. at
1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

Calcium Supplements/Antacids

Co-administration of Alendronate Sodium Oral Solution and calcium, antacids,
or oral medications containing multivalent cations will interfere with
absorption of Alendronate Sodium Oral Solution. Therefore, patients must wait
at least one-half hour after taking Alendronate Sodium Oral Solution before
taking any other oral medications.

Aspirin

In clinical studies, the incidence of upper gastrointestinal adverse events
was increased in patients receiving concomitant therapy with daily doses of
Alendronate Sodium Oral Solution greater than 10 mg and aspirin-containing
products.

Nonsteroidal Anti-Inflammatory Drugs

Alendronate Sodium Oral Solution may be administered to patients taking
nonsteroidal anti-inflammatory drugs (NSAIDs). Since NSAID use is associated
with gastrointestinal irritation, caution should be used during concomitant
use with Alendronate Sodium Oral Solution.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C:

There are no studies in pregnant women. Alendronate Sodium Oral Solution
should be used during pregnancy only if the potential benefit justifies the
potential risk to the mother and fetus.

Nursing Mothers

It is not known whether alendronate is excreted in human milk. Caution should
be exercised when Alendronate Sodium Oral Solution is administered to nursing
women.

Pediatric Use

Alendronate Sodium Oral Solution is not indicated for use in pediatric
patients.

Geriatric Use

No overall differences in efficacy or safety were observed between elderly
patients and younger patients, but greater sensitivity of some older
individuals cannot be ruled out.

Renal Impairment

Alendronate Sodium Oral Solution is not recommended for patients with
creatinine clearance <35 mL/min.

Hepatic Impairment

No dosage adjustment is necessary.

STORAGE AND HANDLING

Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Do
not freeze.

10005270/01 Revised February 2013

© RLI, 2013

CONTACT: For TAGI Pharma, Inc.
         www.tagipharma.com
        
         Kenny Harrington, Vice President of Sales and Marketing
         Phone: 815-624-8523 Ext. 203
         kharrington@precisiondose.com
         or
         Tom Anderson, Executive President
         (Business Development inquiries)
         Phone: 410-241-2165
         tanderson@tagipharma.com