Lawley Pharmaceuticals

Australian pharmaceutical company

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Lawley Pharmaceuticals

Company type| Private
Industry| Pharmaceuticals
Founded| 1995
Founder| Michael John Buckley
Headquarters| Perth, West Leederville, Western Australia

Key people

| Michael Buckley (CEO) & Medical Director
Website| www.lawleypharm.com.au

Lawley Pharmaceuticals is a privately owned Australian pharmaceutical company established by pharmacist Michael Buckley in 1995.[1]

The company specializes in the manufacture of pharmaceutical-grade hormone replacement therapies and is focused on the development of testosterone and progesterone creams for the treatment of various endocrine deficiencies and medical conditions.[2] In Men these disorders include Hypogonadism, Klinefelter's syndrome, low libido and castration. In Women these disorders include Endometriosis, Menopause, PCOS, Fibroids, Female Androgen deficiency, Infertility, Estrogen dominance, Menorrhagia and Hysterectomy.

Over the past 20 years, the company has grown to become a leader in the research and development of transdermal hormone preparations and is advancing clinical research using natural hormones.

## History[edit]

Lawley Pharmaceuticals was founded in 1996[3] as an offshoot from a retail company and is based in Perth, Western Australia.

Since its inception, the company has conducted extensive medical research, with the mission of establishing naturally occurring hormones (bio-identical hormone treatments) as cornerstone treatments for diseases such as breast cancer, infertility, sexual dysfunction, late-onset male hypogonadism, postpartum depression and endometriosis.

Today, Lawley's products have been subjected to clinical studies published in peer-reviewed journals including Menopause,[4] Climacteric[5] and The Journal of Steroid Biochemistry and Molecular Biology.[6]

## Key Executives[edit]

Michael John Buckley is Australian citizen born on 20 May 1961. After attending the St. Kevins College in Melbourne, he went to the Victorian College of Pharmacy from where he received a Bachelor of Pharmacy in 1982.[7] Buckley moved to Perth in 1983 to work as pharmacist in both hospital and retail pharmacy environments.[citation needed]

After an extensive career in the pharmaceutical retail sector, Michael came to the conclusion that bio-identical hormones (Hormones matching chemicals that the body produces) must be better than using synthetic alternatives to treat disorders. To prove this, he devoted his further career to the understanding of the role and effectiveness of bio-identical hormones. Once convinced that bio-identical hormones were superior over their synthetic alternatives, he started the company Lawley Pharmaceuticals in 1995 to manufacture pharmaceutical grade bio-identical hormone creams for use by pharmacies, doctors, and hospitals.[8]

As the CEO and Medical Director of the company, Michael Buckley has directed research and development, clinical trial programs, the meeting of global regulatory requirements and marketing of Lawley’s transdermal hormone preparations.[9]

To date he has developed the optimal delivery systems for the administration of naturally occurring hormones to counter endocrine deficiency states. This success reflects Buckley’s commitment to the use of bio-identical hormones, in preference to a synthetic hormone analogue, specifically the hormones testosterone, progesterone and estradiol.

Michael Buckley is a member of the Australasian Menopause Society, The Pharmaceutical Society of Australia,[10] and The Pharmacy Guild of Australia.

## Manufacturing[edit]

Lawley are manufacturing partners with Perrigo Laboratories Pty Ltd., formerly called Orion Laboratories, in Balcatta, Western Australia. Perrigo is an Australian government approved facility, listed on the Australian Register of Therapeutic Goods.[11] The facility was TGA approved in January 2004 and fully commissioned in August 2004.

## Products[edit]

Company products include AndroForte,[12] AndroFeme[13] and ProFeme, which are all TGA approved.[14]

Product Portfolio  Product Name  | Active Ingredients  | Indication  | ARTG Start Date  | Other products in this category

|
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|
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AndroFeme 1 | Testosterone  | AndroFeme 1% is a transdermal bioidentical testosterone cream designed for women with testosterone deficiency and/or low libido. It was developed due to a rising concern over the lack of testosterone treatment available to women.  | 23-02-2010[15] | N/A
AndroForte 5 | Testosterone  | AndroForte 5% is a transdermal bioidentical testosterone cream. It helps men suffering from Klinefelters syndrome, hypogonadism and low testosterone amongst other diseases.  | 21-10-2009[16] | AndroForte 2S - 2% scrotal testosterone
ProFeme 10 | Progesterone  | ProFeme 10% is a pharmaceutical grade progesterone cream that treats women suffering from low progesterone levels, estrogen dominance and endocrine disorders. This cream covers women’s health issues where hormone replacement therapy is required.  | 02-07-2003[17] | ProFeme 3.2%

## Medical Research and Clinical Trials[edit]

Lawley's research and clinical trials take place in Australia and the United States, where the company is involved in the process of developing and testing new treatment options in therapeutic areas of men's and women's health. Specific areas of interest include andrology, gynaecology, urology and endocrinology.

### Results of Completed Clinical Trials[edit]

Between 2000 and 2004, research by Lawley mainly focused on the clinical efficacy of their creams AndroFeme[18] and AndroForte.[19][20][21]

Results of Lawley's other previous research demonstrated that topically applied progesterone is rapidly absorbed into the skin and transported through the body with a distribution pattern and metabolism comparable to those previously reported for intravascularly administered progesterone.[6][22] In 2003, a study aiming at evaluating the efficacy of transdermal testosterone therapy found that such a treatment improves well-being, mood, and sexual function in pre-menopausal women with low libido and low testosterone.[23][24] Another clinical trial published by Climacteric in 2007, further confirmed that Testosterone cream significantly improves sexual scores in menopausal women with low sexual desire.[25]

One of the most recent studies revealed that for women after menopause a low dose of 5 mg testosterone cream suffices to raise testosterone back to a premenopausal level.[4][26]

### Current Involvement in Research[edit]

The product AndroFeme, an androgen cream for women, is currently being studied in a collaborative study at Boston’s Massachusetts General Hospital conducted by Harvard Medical School Professor Karen K Miller, MD.[10] Other current studies are researching the effects of hormones on different conditions such as Alzheimer's disease, In vitro fertilisation (IVF), Depression,[27] and Dry Eye in postmenopausal women.[28]

## References[edit]

1. ^ "Company Overview of Lawley Pharmaceuticals". www.businessweek.com. Bloomberg Businessweek. Retrieved 17 November 2014.
2. ^ "Company Profile". www.evaluategroup.com. Evaluate Ltd. Retrieved 17 November 2014.
3. ^ "Orbis Report - Lawley Pharmaceuticals". www.orbis.com. Bureau Van Dijk (BvD). Retrieved 16 December 2014.
4. ^ a b Fooladi, Ensieh; Reuter, Stephanie E.; Bell, Robin J.; Robinson, Penelope J.; Davis, Susan R. (May 2014). "Pharmacokinetics of a transdermal testosterone cream in healthy postmenopausal women". Menopause. 22 (1): 44–49. doi:10.1097/GME.0000000000000259. PMID 24845394.
5. ^ El-Hage, G.; Eden, J. A.; Zoa Manga, R. (January 2007). "A double-blind, randomized, placebo-controlled trial of the effect of testosterone cream on the sexual motivation of menopausal hysterectomized women with hypoactive sexual desire disorder". Climacteric. 10 (4): 335–343. doi:10.1080/13697130701364644. PMID 17653960.
6. ^ a b Waddell, Brendan J.; O’Leary, Peter C. (April 2002). "Distribution and metabolism of topically applied progesterone in a rat model". The Journal of Steroid Biochemistry and Molecular Biology. 80 (4–5): 449–455. doi:10.1016/S0960-0760(02)00032-8. PMID 11983492.
7. ^ "Michael Buckley's LinkedIn Profile". www.linkedin.com. LinkedIn Corporation. Retrieved 8 December 2014.
8. ^ "A Short Story by Michael Buckley the CEO of Lawley Pharmaceuticals" (PDF). www.lawleybasecamp.com. Lawley Pharmaceuticals Ltd. Retrieved 8 December 2014.
9. ^ "About Lawley Pharmaceuticals". www.lawleypharm.com.au. Lawley Pharmaceuticals Pty Ltd. Retrieved 8 December 2014.
10. ^ a b "AndroFeme Testosterone Cream for women can improve the way you look and feel". www.completeherbalguide.co.vu. Guide to Natural Healing. Retrieved 19 December 2014.
11. ^ "Australian Approved Manufacturer". www.ebs.tga.gov.au/. TGA - Therapeutic Goods Administration. Retrieved 17 November 2014.
12. ^ "AndroForte 5 Transdermal cream". www.nps.org.au. National Prescribing Service Limited trading as NPS MedicineWise. Retrieved 16 December 2014.
13. ^ McCroy, Winnie. "AndroFeme Provides Hormone Replacement For Women". www.edgeboston.com. EDGE Publications, Inc. Retrieved 16 December 2014.
14. ^ "ARTG, PI and CMI results for Lawley Pharmaceuticals Products". www.tga.gov.au/. Australian Government, Department of Health, Therapeutic Goods Administration. Archived from the original on 8 December 2014. Retrieved 17 November 2014.
15. ^ "Public Summary: AndroFeme 1". www.tga.gov.au. Therapeutic Goods Administration. Retrieved 16 December 2014.
16. ^ "Public Summary: AndroForte 5". www.tga.gov.au. Therapeutic Goods Administration. Retrieved 16 December 2014.
17. ^ "Public Summary: ProFeme 10". www.tga.gov.au. Therapeutic Goods Administration. Retrieved 16 December 2014.
18. ^ Eden, John. "A Pilot Study of AndroFeme Cream (1% Testosterone)" (PDF). www.lawleypharm.com.au/pdfs/trial_pilot-study-androfeme-2000.pdf. Sydney Menopause Centre Royal Hospital for Women: Lawley Pharmaceuticals.
19. ^ "Concord Hospital Research Report" (PDF). 2003. p. 38\. Archived from the original (PDF) on 21 July 2008. Retrieved 4 February 2015.
20. ^ Handelsman, DJ. "Long-Term Pharmacokinetics and Clinical Efficacy of Andromen® Forte 5% Cream for Androgen Replacement Therapy in Hypogonadal Men" (PDF). www.lawleypharm.com.au. ANZAC Research Institute, Department of Andrology, Concord Hospital, Sydney, 2004.
21. ^ Kelleher, S. "Long-Term Pharmacokinetics and Clinical Efficacy of Andromen ® Forte 5% Cream for Androgen Replacement Therapy in Hypogonadal Men". www.academia.edu. ANZAC Research Institute, Department of Andrology, Concord Hospital, Sydney, 2002.
22. ^ O'Leary, P; Feddema, P; Chan, K; Taranto, M; Smith, M; Evans, S (November 2000). "Salivary, but not serum or urinary levels of progesterone are elevated after topical application of progesterone cream to pre-and postmenopausal women". Clinical Endocrinology. 53 (5): 615–20. doi:10.1046/j.1365-2265.2000.01130.x. PMID 11106923.
23. ^ Goldstat, Rebecca; Briganti, Esther; Tran, Jane; Wolfe, Rory; Davis, Susan R. (September 2003). "Transdermal testosterone therapy improves well-being, mood, and sexual function in premenopausal women" (PDF). Menopause. 10 (5): 390–398. CiteSeerX 10.1.1.692.6678. doi:10.1097/01.GME.0000060256.03945.20. PMID 14501599.
24. ^ Abdallah, R T; Simon, J A (21 June 2007). "Testosterone therapy in women: its role in the management of hypoactive sexual desire disorder". International Journal of Impotence Research. 19 (5): 458–463. doi:10.1038/sj.ijir.3901558. PMID 17581596.
25. ^ El-Hage, G; Eden, JA; Manga, RZ (August 2007). "A double-blind, randomized, placebo-controlled trial of the effect of testosterone cream on the sexual motivation of menopausal hysterectomized women with hypoactive sexual desire disorder". Climacteric. 10 (4): 335–43. doi:10.1080/13697130701364644. PMID 17653960.
26. ^ "How much testosterone is too much for women after menopause?". www.sciencedaily.com. ScienceDaily LLC.
27. ^ "Collaborative Study: Testosterone Antidepressant Augmentation in Women". www2.massgeneral.org/crp/. Massachusetts General Hospital Clinical Research Program. Archived from the original on 4 February 2015. Retrieved 4 February 2015.
28. ^ Buckley, Michael. "Lawley bio-identical research and clinical trials are happening around the world". www.hormonesolutions.com. Lawley Pharmaceuticals Ltd.

## External links[edit]

* Company Facebook Page
* Product and information Site
* Bio-identical Testosterone and Progesterone Creams